data.medicaid.govHand-written summary
Drug Products in the Medicaid Drug Rebate Program
Active drugs reported by manufacturers under the Medicaid Drug Rebate Program, by National Drug Code, with package, approval, market date and other product details.
Freshness
- Last posted
- Period covered
- Update frequency
Dates as CMS lists them in its catalog.
Before you use it
- Each quarter is a snapshot of the system at that time and is not updated by later changes.
Columns 24
| Column | What it means | Type |
|---|---|---|
Yearyear | string | |
Quarterquarter | string | |
Labeler Namelabeler_name | The corporate name of the entity identified by the labeler code. | string |
NDCndc | The National Drug Code (NDC) is a numerical code maintained by the FDA that includes the labeler code, product code, and package code. The NDC is an 11-digit code. | string |
Labeler Codelabeler_code | The first segment of the National Drug Code that identifies the labeler. | string |
Product Codeproduct_code | The second segment of the National Drug Code that identifies the product. | string |
Package Size Codepackage_size_code | The third segment of the National Drug Code that identifies the package size. | string |
Drug Categorydrug_category | This field indicates whether the drug is single source (S), innovator multiple source(I), or non- innovator multiple source (N). Valid Values: N = Non-innovator multiple source S = Single source I = Innovator multiple source | string |
Drug Type Indicatordrug_type_indicator | This field identifies a drug as prescription (Rx) or Over-the-Counter (OTC). Valid values: 1 = Rx 2 = OTC | integer |
Termination Datetermination_date | The date on which the drug was withdrawn from market or the drug's last lot expiration date. | date |
Unit Typeunit_type | One of the 8 unit types by which a drug can be dispensed. Valid Values: AHF = Injectable Anti-Hemophilic Factor CAP = Capsule SUP = Suppository GM = Gram ML = Milliliter TAB = Tablet TDP = Transdermal | string |
Units Per Pkg Sizeunits_per_pkg_size | The total number of units in the smallest dispensable amount for the 11-digit NDC. | string |
FDA Approval Datefda_approval_date | The NDC or monograph approval date. | date |
Market Datemarket_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. Thus, the Market Date of a drug is frequently not the date on which a labeler began marketing the drug, but may be a much earlier date. If a Market Date falls on a date that is earlier than 9/30/1990, CMS will change it to 9/30/1990 in both the Medicaid Drug Rebate (MDR) system and the Drug Data Reporting for Medicaid (DDR) system since dates earlier than the start of the Drug Rebate Program have no bearing on the program. Numeric values, 8-digit field, format: MM/DD/YYYY. | date |
FDA Therapeutic Equivalence Codefda_therapeutic_equivalence_code | The Therapeutic Equivalence Code (TEC) reported to CMS should correspond to the FDA Therapeutic Equivalence (TE) Code assigned to a product by the FDA. More information regarding FDA TE Codes can be found at the Orange Book at: http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm or Drugs@FDA at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Addlsearch_drug name. It is important to note that while the FDA generally assigns a two letter TE Code value (e.g., AB) to products, in some cases the value is two letters plus a number (e.g., AB1). Since DDR restricts values reported in the TEC field to two characters, some FDA TE Codes need to be converted to a two-character format. Specifically, if the FDA assigned TE Code is AB1, AB2, etc., the corresponding TEC value should be reported in DDR as A1, A2, etc. Alpha-numeric values, 2 character field. Valid Values: A1 A6 AB BC BR A2 A7 AN BD BS A3 A8 AO BE BT A4 A9 AP BN BX A5 AA AT BP NR (Not Rated) | string |
FDA Product Namefda_product_name | The drug's name as approved by the FDA. | string |
Clotting Factor Indicatorclotting_factor_indicator | In accordance with section 1927(c)(1)(B)(iii) of the Social Security Act, an indicator which identifies a Single Source or Innovator Multiple Source drug as a clotting factor for which a separate furnishing payment is made under section 1842(o)(5) of the Act. Valid values: Y = Yes N = No | string |
Pediatric Indicatorpediatric_indicator | In accordance with section 1927(c)(1)(B)(iii) of the Social Security Act, an indicator which identifies a Single Source or Innovator Multiple Source drug approved by the FDA exclusively for pediatric indications for patients in the FDA-defined pediatric age group (i.e., birth to 16 years). Valid values: Y = Yes N = No | string |
Package Size Intro Datepackage_size_intro_date | The date the package size is first available on the market. If the product was purchased from another company, the Package Size Introduction Date should equal the date the package size is first available on the market under the labeler code of the company currently holding legal title to the NDC. | date |
Purchased Product Datepurchased_product_date | The date on which 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…). | date |
COD Statuscod_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. Valid Values: ' ' (Spaces) = The Labeler has not reported this field to the Medicaid Drug Rebate Program. '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) *NDCs with a COD Status of DESI 5/6 are not eligible for coverage or rebates under the Medicaid Drug Rebate Program. | string |
FDA Application Numberfda_application_number | For drugs with a COD status of ANDA, BLA, NDA, or NDA Authorized Generic, this is the seven-digit application number that is assigned by the FDA for approval to market a generic drug or new drug in the United States • For drugs with a COD status of OTC Monograph Tentative or Final, this is the FDA's August 2018 Page 5 of 5 regulatory citation for the OTC • 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 area constant of 'PART'; the last three characters are the numeric values for the appropriate regulatory citation for the product, or 3 zeroes 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 No./OTC Monograph No. field will be zero-filled For drugs where a COD Status has never been reported to CMS, the FDA Application Number/OTC Monograph Number field will be padded with spaces. | string |
Reactivation Datereactivation_date | The date on which a terminated product is re-introduced to the market. | string |
Line Extension Drug Indicatorline_extension_drug_indicator | Identifies whether or not a product is a line extension drug as defined inSection 1927(c)(2)(C) of the Social SecurityAct, including whether the drug is excluded from the statutory definition of a line extension on the basis of being an abuse-deterrent formulation (ADF). 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) | string |
No column matches that filter.
At a glance
- Catalog
- data.medicaid.gov
- Publisher
- Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov
- Rows
- 2,002,508
- Columns
- 24
- State column
- None found
- Contact
- Medicaid.gov@cms.hhs.gov
API
Free, no key needed. This request returns the first 10 rows as JSON:
https://data.medicaid.gov/api/1/datastore/query/0ad65fe5-3ad3-5d79-a3f9-7893ded7963a/0?limit=10
CMS's description
Active drugs that have been reported by participating drug manufacturers under the Medicaid Drug Rebate Program. All drugs are identified by National Drug Code (NDC), unit type, units per package size, product name, Food and Drug Administration (FDA) approval date, the date the drug entered the market, plus indicators to show whether the drug is an innovator or non-innovator drug; whether it is available by prescription or over-the-counter (OTC); the FDA therapeutic equivalency code; and the Drug Efficacy Study Implementation (DESI) rating and termination date. Each quarter posted represents a snapshot of data in the system at that time and is not updated by subsequent changes.
The summary at the top was written by hand from this description. Record id mcd:0ad65fe5-3ad3-5d79-a3f9-7893ded7963a. This record as JSON.