{"identifier":"66f843c8-1180-4244-8adc-554d02584fa4","data":{"title":"Newly Reported Drugs Data Dictionary","fields":[{"name":"ndc1","title":"NDC1","type":"string","format":"default","description":"Labeler Code - First segment of National Drug Code (NDC1) that identifies the manufacturer, labeler, relabeler, packager, repackager or distributor of the drug.","constraints":{"maxLength":5}},{"name":"ndc2","title":"NDC2","type":"string","format":"default","description":"Product Code - Second segment of National Drug Code (NDC2)","constraints":{"maxLength":4}},{"name":"ndc3","title":"NDC3","type":"string","format":"default","description":"Package Size - Third segment of National Drug Code (NDC3)","constraints":{"maxLength":2}},{"name":"labeler_name","title":"Labeler Name","type":"string","format":"default","description":"Labeler Name: Name of labeler as it appears on the signed rebate agreement."},{"name":"labeler_status","title":"Labeler Status","type":"string","format":"default","description":"Labeler Status: Active or Terminated","constraints":{"maxLength":10}},{"name":"fda_name","title":"FDA Name","type":"string","format":"default","description":"The FDA Name should reflect the drug\u0027s name as reported to FDA; therefore, the FDA Name reported to CMS should correspond to the drug name on file with the FDA."},{"name":"cod_status","title":"COD Status","type":"string","format":"default","description":"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.\r\nValid Values:\r\n01 = Abbreviated New Drug Application (ANDA)\r\n02 = Biological License Application (BLA)\r\n03 = New Drug Application (NDA)\r\n04 = NDA Authorized Generic\r\n05 = DESI 5* - LTE\/IRS drug for all indications\r\n06 = DESI 6* - LTE\/IRS drug withdrawn from market \u201c07\u201d = Prescription Pre-Natal Vitamin or Fluoride\r\n08 = Prescription Dietary Supplement\/Vitamin\/Mineral (Other than Prescription Pre-Natal Vitamin or Fluoride)\r\n09 = OTC Monograph Tentative\r\n10 = OTC Monograph Final\r\n11 = Unapproved Drug - Drug Shortage\r\n12 = Unapproved Drug - Per 1927(k)(2)(A)(ii)\r\n13 = Unapproved Drug - Per 1927(k)(2)(A)(iii)\r\nSpaces = The Labeler has not reported this field to the Medicaid Drug Rebate Program.\r\n* NDCs with a COD Status of DESI 5\/6 are not eligible for coverage or rebates under the Medicaid Drug Rebate Program.","constraints":{"maxLength":2}},{"name":"fda_application_number","title":"FDA Application Number","type":"string","format":"default","description":"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.\r\nFor drugs with a COD status of OTC Monograph Tentative or Final, this is the FDA\u0027s 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 \u201cPART\u201d; the last three characters are the numeric values for the appropriate regulatory citation for the product (e.g., \u201c225\u201d). For drugs with a COD Status of OTC Monograph Tentative, the first four characters are a constant of \u201cPART\u201d; 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.\r\nFor 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.","constraints":{"maxLength":7}},{"name":"drug_category","title":"Drug Category","type":"string","format":"default","description":"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.\r\nValid Values:\r\nN = Non-innovator multiple source\r\nS = Single source\r\nI = Innovator multiple source","constraints":{"maxLength":1}},{"name":"drug_type","title":"Drug Type","type":"string","format":"default","description":"Drug Type: Identifies a drug as prescription (Rx) or Over-the-Counter (OTC). Numeric values; 1-digit field.\r\nValid Values:\r\n1 = Rx\r\n2 = OTC","constraints":{"maxLength":3}},{"name":"line_extension","title":"Line Extension","type":"string","format":"default","description":"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 \u201cR\u201d will appear in this field. Note: If a Line Extension Drug Indicator has not been reported for an NDC, this field will be blank.\r\nValid Values:\r\nY = Yes\r\nN = No (i.e., neither LE nor ADF)\r\nR = Request for ADF Exclusion\r\nE = Excluded (Due to ADF) Note: This value may only be assigned by CMS","constraints":{"maxLength":1}},{"name":"fda_approval_date","title":"FDA Approval Date","type":"date","format":"%m\/%d\/%Y","description":"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."},{"name":"market_date","title":"Market Date","type":"date","format":"%m\/%d\/%Y","description":"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."},{"name":"unit_type","title":"Unit Type","type":"string","format":"default","description":"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.\r\nValid Values:\r\nAHF = Injectable Anti-Hemophilic Factor\r\nCAP = Capsule\r\nEA = Each\r\nGM = Gram\r\nMCI = Millicurie\r\nML = Milliliter\r\nUCI = Microcurie\r\nSUP = Suppository\r\nTAB = Tablet\r\nTDP = Transdermal patch","constraints":{"maxLength":3}},{"name":"unit_per_package_size","title":"Unit Per Package Size","type":"string","format":"default","description":"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 (\u2018.\u0027) and 3 decimal places; right-justified; zero-padded for UPPS values with fewer than 11 digits."},{"name":"therapeutic_equivalent_code","title":"Therapeutic Equivalent Code","type":"string","format":"default","description":"Therapeutic Equivalence Code (TEC): FDA-assigned Therapeutic Equivalence Codes as found in the FDA\u0027s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Alpha-numeric values; 2-digit field.\r\nValid Values:\r\nAA = Products in Conventional Dosage Forms Not Presenting Bioequivalence Problems\r\nAB = Products Meeting Necessary Bioequivalence Requirements assigned an FDA TEC of AB, or AB1 through AB9\r\nAN = Solutions and Powders for Aerosolization\r\nAO = Injectable Oil Solutions\r\nAP = Injectable Aqueous Solutions and, in Certain Instances, Intravenous Non-Aqueous\r\nAT = Topical Products\r\nBC = Extended-Release Dosage Forms (Capsules, Injectables, and Tablets)\r\nBD = Active Ingredients and Dosage Form With Documented Bioequivalence Problems\r\nBE = Delayed-Release Oral Dosage Forms\r\nBN = Products in Aerosol-Nebulizer Drug Delivery Systems\r\nBP = Active Ingredients and Dosage Forms with Potential Bioequivalence Problems\r\nBR = Suppositories or Enemas That Deliver Drugs for Systemic Absorption\r\nBS = Products Having Drug Standard Deficiencies\r\nBT = Topical Products with Bioequivalence Issues\r\nBX = Drug Products for Which the Data Are Insufficient To Determine Therapeutic Equivalence\r\nNR = Not Rated","constraints":{"maxLength":2}},{"name":"5i_indicator","title":"5i Indicator","type":"string","format":"default","description":"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)","constraints":{"maxLength":1}},{"name":"purchased_product_date","title":"Purchased Product Date","type":"date","format":"%m\/%d\/%Y","description":"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\u0027s labeler codes to another of that same company\u0027s labeler codes, cross-licensing arrangements, etc.). Zero or blank-filled for drugs without Purchased Product Dates."},{"name":"coverage_effective_date","title":"Coverage Effective Date","type":"date","format":"%m\/%d\/%Y","description":"The Coverage Effective Date field reflects the date on which a product is first eligible for coverage under the MDRP."},{"name":"drug_termination_date","title":"Drug Termination Date","type":"date","format":"%m\/%d\/%Y","description":"Termination Date: The date on which the drug was withdrawn from market or the drug\u0027s last lot expiration date."},{"name":"drug_reactivation_date","title":"Drug Reactivation Date","type":"date","format":"%m\/%d\/%Y","description":"Reactivation Date: The date on which a terminated product is re-introduced to the market."},{"name":"date_reported_to_cms","title":"Date Reported to CMS","type":"date","format":"%m\/%d\/%Y","description":"Date Reported to CMS: The date on which the product was initially reported to CMS via MDP"}]}}