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Product Data for Newly Reported Drugs in the Medicaid Drug Rebate Program

The data below 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...

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Dates as CMS lists them in its catalog.

Columns 22

ColumnWhat it meansType
NDC1ndc1Labeler Code - First segment of National Drug Code (NDC1) that identifies the manufacturer, labeler, relabeler, packager, repackager or distributor of the drug.string
NDC2ndc2Product Code - Second segment of National Drug Code (NDC2)string
NDC3ndc3Package Size - Third segment of National Drug Code (NDC3)string
Labeler Namelabeler_nameLabeler Name: Name of labeler as it appears on the signed rebate agreement.string
Labeler Statuslabeler_statusLabeler Status: Active or Terminatedstring
FDA Namefda_nameThe 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.string
COD Statuscod_statusCovered 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(NDA) 04 = NDA Authorized Generic 05 = DESI 5* - LTE/IRS drug for all indications 06 = DESI 6* - LTE/IRS drug withdrawn from market “07” = Prescription Pre-Natal Vitamin or Fluoride 08 = Prescription Dietary Supplement/Vitamin/Mineral (Other than Prescription Pre-Natal Vitamin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.string
FDA Application Numberfda_application_numberFDA 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.string
Drug Categorydrug_categoryDrug 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 sourcestring
Drug Typedrug_typeDrug Type: Identifies a drug as prescription (Rx) or Over-the-Counter (OTC). Numeric values; 1-digit field. Valid Values: 1 = Rx 2 = OTCstring
Line Extensionline_extensionLine 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 CMSstring
FDA Approval Datefda_approval_dateFDA 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.date
Market Datemarket_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. 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.date
Unit Typeunit_typeUnit 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 patchstring
Unit Per Package Sizeunit_per_package_sizeUnits 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.string
Therapeutic Equivalent Codetherapeutic_equivalent_codeTherapeutic 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 Ratedstring
5i Indicator5i_indicatorThe 5i Drug Indicator specifies whether or not the product is a 5i drug (i.e., inhaled, instilled, implanted, injected, or infused). (Y or N)string
Purchased Product Datepurchased_product_datePurchased 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.date
Coverage Effective Datecoverage_effective_dateThe Coverage Effective Date field reflects the date on which a product is first eligible for coverage under the MDRP.date
Drug Termination Datedrug_termination_dateTermination Date: The date on which the drug was withdrawn from market or the drug's last lot expiration date.date
Drug Reactivation Datedrug_reactivation_dateReactivation Date: The date on which a terminated product is re-introduced to the market.date
Date Reported to CMSdate_reported_to_cmsDate Reported to CMS: The date on which the product was initially reported to CMS via MDPdate

At a glance

Catalog
data.medicaid.gov
Publisher
Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov
Rows
91
Columns
22
State column
None found
Topics
Prescription drugs, Medicaid and CHIP, Spending and use of services
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/0c1f13ac-47dd-4d75-80d1-f3f2a706d615/0?limit=10

Versions 131

The newest version is the one linked above. Older releases stay on the official site.

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CMS's description

The data below 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.

The summary at the top is the first sentence of this description. Record id mcd:0c1f13ac-47dd-4d75-80d1-f3f2a706d615. This record as JSON.

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