[ROWS] 932
[FIELDS] 17
[MODIFIED] 2021-10-13
[DOWNLOAD] https://data.medicaid.gov/sites/default/files/uploaded_resources/newly-reported-drugs-october-files.csv
[DICTIONARY] https://data.medicaid.gov/api/1/metastore/schemas/data-dictionary/items/66f843c8-1180-4244-8adc-554d02584fa4
32 Drug Rebate Program
Product Data for Newly Reported Drugs in the Medicaid Drug Rebate Program
The Table below, updated weekly, contains newly reported, active covered outpatient drugs which were reported by participating drug manufacturers since the last quarterly update of the Drug Products in the Medicaid Drug Rebate Program (MDRP) database. Each file on this table represents a snapshot of data in the system and is not updated by subsequent changes. Once the covered outpatient drugs in each of these files appear in the quarterly MDRP database, the file will be removed from this table. States can utilize these files to identify newly reported covered outpatient drugs.
Metadata
Dictionary
ndc1
Labeler Code - First segment of National Drug Code
(NDC1) that identifies the manufacturer, labeler,
relabeler, packager, repackager or distributor of
the drug.
ndc2
Product Code - Second segment of National Drug
Code (NDC2)
ndc3
Package Size - Third segment of National Drug Code
(NDC3)
labeler_name
Labeler Name: Name of labeler as it appears on the
signed rebate agreement.
labeler_status
Labeler Status: Active or Terminated
fda_name
The FDA Name should reflect the drug's name as
reported to FDA; therefore, the FDA Name reported
to CMS should correspond to the drug name on file
with the FDA.
cod_status
Covered Outpatient Drug (COD) Status: A category
that identifies whether or not a product meets
the statutory definition of a covered outpatient
drug in accordance with sections 1927(k)(2) to
1927(k)(4) of the Social Security Act. Numeric
values; 8-digit field; format: MMDDYYYY. Valid
Values: 01 = Abbreviated New Drug Application
(ANDA) 02 = Biological License Application
(BLA) 03 = New Drug Application (NDA) 04 = NDA
Authorized Generic 05 = DESI 5* - LTE/IRS drug
for all indications 06 = DESI 6* - LTE/IRS
drug withdrawn from market 07 = Prescription
Pre-Natal Vitamin or Fluoride 08 = Prescription
Dietary Supplement/Vitamin/Mineral (Other than
Prescription Pre-Natal Vitamin or Fluoride) 09
= OTC Monograph Tentative 10 = OTC Monograph
Final 11 = Unapproved Drug - Drug Shortage 12
= Unapproved Drug - Per 1927(k)(2)(A)(ii) 13 =
Unapproved Drug - Per 1927(k)(2)(A)(iii) Spaces
= The Labeler has not reported this field to the
Medicaid Drug Rebate Program. * NDCs with a COD
Status of DESI 5/6 are not eligible for coverage
or rebates under the Medicaid Drug Rebate Program.
fda_application_number
FDA Application Number/OTC Monograph Number: For
drugs with a COD status of ANDA, BLA, NDA, or
NDA Authorized Generic, this is the application
number (assigned by the FDA for approval to market
a drug or biological in the United States) under
which the NDC is currently marketed. Numeric
values; 7-digit field; padded with leading zeros
as needed. For drugs with a COD status of OTC
Monograph Tentative or Final, this is the FDA's
regulatory citation for the OTC. Alpha-numeric
values; 7-digit field. For drugs with a COD
Status of OTC Monograph Final, the first four
characters are a constant of PART; the last
three characters are the numeric values for the
appropriate regulatory citation for the product
(e.g., 225). For drugs with a COD Status of OTC
Monograph Tentative, the first four characters
are a constant of PART; the last three characters
are the numeric values for the appropriate
regulatory citation for the product, or three
zeros if a Monograph Number is not available.
For drugs with a COD Status other than ANDA, BLA,
NDA, NDA Authorized Generic, OTC Monograph Final,
or OTC Monograph Tentative, the FDA Application
Number/OTC Monograph Number field should be
zero-filled.
drug_category
Drug Category: This field indicates whether the
drug is single source (S), innovator multiple
source (I), or non-innovator multiple source (N).
1-character field. Valid Values: N = Non-innovator
multiple source S = Single source I = Innovator
multiple source
drug_type
Drug Type: Identifies a drug as prescription (Rx)
or Over-the-Counter (OTC). Numeric values; 1-digit
field. Valid Values: 1 = Rx 2 = OTC
line_extension
Line Extension Drug Indicator: Identifies whether
a product is a line extension drug as defined
in Section 1927(c)(2)(C) of the Social Security
Act, including whether the drug is excluded from
the statutory definition of a line extension on
the basis of being an abuse-deterrent formulation
(ADF). If a labeler is seeking an ADF exclusion,
a value of R will appear in this field. Note:
If a Line Extension Drug Indicator has not been
reported for an NDC, this field will be blank.
Valid Values: Y = Yes N = No (i.e., neither LE nor
ADF) R = Request for ADF Exclusion E = Excluded
(Due to ADF) Note: This value may only be assigned
by CMS
fda_approval_date
FDA Approval Date: NDA (including Authorized
Generic), ANDA or BLA approval date. For covered
outpatient drugs for which the FDA does not
require approval, the FDA Approval Date will be
09/30/1990, or, if the drug was first marketed
after 09/30/1990, the actual date the drug was
first marketed.
market_date
Market Date: For S, I, and N drugs marketed under
an FDA-approved application (e.g. BLA, NDA, ANDA),
the earliest date the drug was first marketed
under the application number by any labeler.
For drugs marketed without an FDA-approved
application (e.g. OTC monograph, unapproved drug),
the earliest date the drug was first marketed by
any labeler. For all drugs (i.e., those marketed
with or without an FDA-approved application), if
a drug was purchased or otherwise acquired from
another labeler, the Market Date should be equal
to the Market Date of the original product. If a
Market Date falls on a date that is earlier than
9/30/1990, CMS will change it to 9/30/1990 in the
Medicaid Drug Programs (MDP) system since dates
earlier than the start of the Drug Rebate Program
have no bearing on the program.
unit_type
Unit Type: One of the 10 unit types by which
a drug may be dispensed. 3-character field;
left-justified; blank-filled for Unit Type values
with fewer than 3 characters. Valid Values: AHF =
Injectable Anti-Hemophilic Factor CAP = Capsule EA
= Each GM = Gram MCI = Millicurie ML = Milliliter
UCI = Microcurie SUP = Suppository TAB = Tablet
TDP = Transdermal patch
unit_per_package_size
Units Per Package Size: The total number of
units in the smallest dispensable amount for the
11-digit NDC. Numeric values; 11-digit field:
7 whole numbers, the decimal point (.') and 3
decimal places; right-justified; zero-padded for
UPPS values with fewer than 11 digits.
therapeutic_equivalent_code
Therapeutic Equivalence Code (TEC): FDA-assigned
Therapeutic Equivalence Codes as found in the
FDA's Orange Book: Approved Drug Products with
Therapeutic Equivalence Evaluations. Alpha-numeric
values; 2-digit field. Valid Values: AA = Products
in Conventional Dosage Forms Not Presenting
Bioequivalence Problems AB = Products Meeting
Necessary Bioequivalence Requirements assigned an
FDA TEC of AB, or AB1 through AB9 AN = Solutions
and Powders for Aerosolization AO = Injectable Oil
Solutions AP = Injectable Aqueous Solutions and,
in Certain Instances, Intravenous Non-Aqueous AT
= Topical Products BC = Extended-Release Dosage
Forms (Capsules, Injectables, and Tablets) BD =
Active Ingredients and Dosage Form With Documented
Bioequivalence Problems BE = Delayed-Release Oral
Dosage Forms BN = Products in Aerosol-Nebulizer
Drug Delivery Systems BP = Active Ingredients
and Dosage Forms with Potential Bioequivalence
Problems BR = Suppositories or Enemas That Deliver
Drugs for Systemic Absorption BS = Products Having
Drug Standard Deficiencies BT = Topical Products
with Bioequivalence Issues BX = Drug Products
for Which the Data Are Insufficient To Determine
Therapeutic Equivalence NR = Not Rated
5i_indicator
The 5i Drug Indicator specifies whether or not the
product is a 5i drug (i.e., inhaled, instilled,
implanted, injected, or infused). (Y or N)
purchased_product_date
Purchased Product Date (PPD): The date the company
currently holding legal title to the NDC first
markets the drug under this NDC (this date can
result, for example, from the purchase of an
NDC from one company by another company, the
re-designation of an NDC from one of a company's
labeler codes to another of that same company's
labeler codes, cross-licensing arrangements,
etc.). Zero or blank-filled for drugs without
Purchased Product Dates.
coverage_effective_date
The Coverage Effective Date field reflects the
date on which a product is first eligible for
coverage under the MDRP.
drug_termination_date
Termination Date: The date on which the drug
was withdrawn from market or the drug's last lot
expiration date.
drug_reactivation_date
Reactivation Date: The date on which a terminated
product is re-introduced to the market.
date_reported_to_cms
Date Reported to CMS: The date on which the
product was initially reported to CMS via MDP
Data
# A tibble: 932 × 17
ndc1 ndc2 ndc3 ndc11 fda_nameproduct_name cod_status
,
# drug_category , drug_type , unit_type , upps ,
# line_extension , tec_code , fda_approval_date ,
# market_date , termination_date , date_transferred
Overview
resp (932 rows and 17 variables, 16 shown)
ID | Name | Type | Missings
---+--------------------------------------------+-------------+------------
1 | ndc1 | character | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
2 | ndc2 | character | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
3 | ndc3 | character | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
4 | ndc11 | character | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
5 | fda_nameproduct_name | character | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
6 | cod_status | categorical | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
7 | fda_application_numberotc_monograph_number | character | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
8 | drug_category | categorical | 0 (0.0%)
| | |
| | |
---+--------------------------------------------+-------------+------------
9 | drug_type | categorical | 0 (0.0%)
| | |
---+--------------------------------------------+-------------+------------
10 | unit_type | categorical | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
11 | upps | numeric | 0 (0.0%)
---+--------------------------------------------+-------------+------------
13 | tec_code | categorical | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
14 | fda_approval_date | date | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
15 | market_date | date | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---+--------------------------------------------+-------------+------------
16 | termination_date | date | 929 (99.7%)
| | |
| | |
---+--------------------------------------------+-------------+------------
17 | date_transferred | date | 0 (0.0%)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
---------------------------------------------------------------------------
ID | Values | N
---+-------------------------------------------------------+------------
1 | 00006 | 1 ( 0.1%)
| 00023 | 2 ( 0.2%)
| 00024 | 8 ( 0.9%)
| 00054 | 1 ( 0.1%)
| 00074 | 1 ( 0.1%)
| 00075 | 7 ( 0.8%)
| 00088 | 1 ( 0.1%)
| 00093 | 10 ( 1.1%)
| 00113 | 6 ( 0.6%)
| 00115 | 4 ( 0.4%)
| (...) |
---+-------------------------------------------------------+------------
2 | 0001 | 4 ( 0.4%)
| 0002 | 1 ( 0.1%)
| 0003 | 1 ( 0.1%)
| 0005 | 1 ( 0.1%)
| 0009 | 1 ( 0.1%)
| 0010 | 1 ( 0.1%)
| 0011 | 2 ( 0.2%)
| 0012 | 2 ( 0.2%)
| 0013 | 2 ( 0.2%)
| 0014 | 5 ( 0.5%)
| (...) |
---+-------------------------------------------------------+------------
3 | 00 | 15 ( 1.6%)
| 01 | 251 (26.9%)
| 02 | 53 ( 5.7%)
| 03 | 30 ( 3.2%)
| 04 | 21 ( 2.3%)
| 05 | 52 ( 5.6%)
| 06 | 28 ( 3.0%)
| 07 | 11 ( 1.2%)
| 08 | 9 ( 1.0%)
| 09 | 25 ( 2.7%)
| (...) |
---+-------------------------------------------------------+------------
4 | 00006533101 | 1 ( 0.1%)
| 00023350731 | 1 ( 0.1%)
| 00023715160 | 1 ( 0.1%)
| 00024279201 | 1 ( 0.1%)
| 00024279401 | 1 ( 0.1%)
| 00024590800 | 1 ( 0.1%)
| 00024591000 | 1 ( 0.1%)
| 00024591900 | 1 ( 0.1%)
| 00024591902 | 1 ( 0.1%)
| 00024592000 | 1 ( 0.1%)
| (...) |
---+-------------------------------------------------------+------------
5 | 2.5% Dextrose and 0.45% Sodium Chl Liquid 25 g 1000mL | 1 ( 0.1%)
| Abiraterone Tabs | 1 ( 0.1%)
| Acetaminophen ER 650mg | 1 ( 0.1%)
| ACUVAIL 0.45% 30 x 0.4 mL FW | 1 ( 0.1%)
| Acyclovir 200mg/5ml, 473ml bottle | 1 ( 0.1%)
| Aemcolo | 1 ( 0.1%)
| AKOVAZ-EPHEDRINE SULFATE INJECTION 50MG/ML VIAL | 1 ( 0.1%)
| AKOVAZ 50MG/ML | 1 ( 0.1%)
| Alaway Preservative Free Antihistamine Eye Drops | 1 ( 0.1%)
| Albuterol Sulfate Inhalant | 1 ( 0.1%)
| (...) |
---+-------------------------------------------------------+------------
6 | 01 | 628 (67.4%)
| 02 | 39 ( 4.2%)
| 03 | 177 (19.0%)
| 04 | 23 ( 2.5%)
| 07 | 9 ( 1.0%)
| 08 | 1 ( 0.1%)
| 09 | 26 ( 2.8%)
| 10 | 24 ( 2.6%)
| 12 | 5 ( 0.5%)
---+-------------------------------------------------------+------------
7 | | 14 ( 1.5%)
| 0000000 | 1 ( 0.1%)
| 0014602 | 1 ( 0.1%)
| 0017422 | 1 ( 0.1%)
| 0017555 | 2 ( 0.2%)
| 0018074 | 1 ( 0.1%)
| 0018651 | 1 ( 0.1%)
| 0018741 | 2 ( 0.2%)
| 0018965 | 1 ( 0.1%)
| 0019018 | 1 ( 0.1%)
| (...) |
---+-------------------------------------------------------+------------
8 | I | 105 (11.3%)
| N | 693 (74.4%)
| S | 134 (14.4%)
---+-------------------------------------------------------+------------
9 | 1 | 856 (91.8%)
| 2 | 76 ( 8.2%)
---+-------------------------------------------------------+------------
10 | AHF | 1 ( 0.1%)
| CAP | 149 (16.0%)
| EA | 74 ( 7.9%)
| GM | 55 ( 5.9%)
| ML | 209 (22.4%)
| SUP | 1 ( 0.1%)
| TAB | 439 (47.1%)
| TDP | 4 ( 0.4%)
---+-------------------------------------------------------+------------
11 | [0.14, 1000] | 932
---+-------------------------------------------------------+------------
13 | A1 | 1 ( 0.1%)
| A3 | 4 ( 0.4%)
| AA | 31 ( 3.3%)
| AB | 539 (57.8%)
| AN | 8 ( 0.9%)
| AP | 103 (11.1%)
| AT | 5 ( 0.5%)
| BE | 1 ( 0.1%)
| BP | 1 ( 0.1%)
| NR | 239 (25.6%)
---+-------------------------------------------------------+------------
14 | 1990-09-30 | 57 ( 6.1%)
| 1991-10-31 | 3 ( 0.3%)
| 1991-12-23 | 5 ( 0.5%)
| 1992-02-10 | 1 ( 0.1%)
| 1992-06-19 | 2 ( 0.2%)
| 1992-07-31 | 2 ( 0.2%)
| 1992-10-29 | 2 ( 0.2%)
| 1993-03-29 | 2 ( 0.2%)
| 1993-10-01 | 1 ( 0.1%)
| 1993-12-16 | 1 ( 0.1%)
| (...) |
---+-------------------------------------------------------+------------
15 | 1990-09-30 | 57 ( 6.1%)
| 1991-10-31 | 3 ( 0.3%)
| 1991-12-23 | 5 ( 0.5%)
| 1992-02-10 | 1 ( 0.1%)
| 1992-06-19 | 2 ( 0.2%)
| 1992-07-31 | 2 ( 0.2%)
| 1992-10-29 | 2 ( 0.2%)
| 1993-03-29 | 2 ( 0.2%)
| 1993-10-01 | 1 ( 0.1%)
| 1993-12-16 | 1 ( 0.1%)
| (...) |
---+-------------------------------------------------------+------------
16 | 2018-02-10 | 1 (33.3%)
| 2018-06-06 | 1 (33.3%)
| 2022-03-31 | 1 (33.3%)
---+-------------------------------------------------------+------------
17 | 2021-07-26 | 19 ( 2.0%)
| 2021-07-27 | 24 ( 2.6%)
| 2021-07-28 | 36 ( 3.9%)
| 2021-07-29 | 70 ( 7.5%)
| 2021-07-30 | 29 ( 3.1%)
| 2021-07-31 | 1 ( 0.1%)
| 2021-08-02 | 22 ( 2.4%)
| 2021-08-03 | 13 ( 1.4%)
| 2021-08-04 | 2 ( 0.2%)
| 2021-08-11 | 42 ( 4.5%)
| (...) |
------------------------------------------------------------------------
Distribution
Variable | Mean | SD | IQR | Range | Skewness | Kurtosis | n | n_Missing
-----------------------------------------------------------------------------------------
upps | 86.62 | 185.27 | 99 | [0.14, 1000.00] | 3.60 | 13.55 | 932 | 0
