Provera

Orange BookUNIISPLATC L02AB02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPharmacia & Upjohn Company LLC

CountryUS (United States)

ATC codeL02AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0009005101
100 TABLET in 1 BOTTLE (0009-0051-01)

Annotations

UNII (FDA Substance ID)

C2QI4IOI2G

MEDROXYPROGESTERONE ACETATE

RxCUI 1000112

Orange Book

N011839

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "C2QI4IOI2G",
    "rxcui": "1000112",
    "inchikey": "PSGAAPLEWMOORI-PEINSRQWSA-N",
    "display_name": "MEDROXYPROGESTERONE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "a586be28-96af-4fed-a13f-9b94fd4c7405": {
      "match": "brand_token",
      "title": "PROVERA (MEDROXYPROGESTERONE ACETATE) TABLET [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "26",
      "published_date": "2024-09-02"
    }
  },
  "productid": "0009-0051_80c81ad8-3d42-4a21-ac4c-d331bc5e4956",
  "productndc": "0009-0051",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "011839",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEDROXYPROGESTERONE ACETATE",
  "proprietary_name": "Provera",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA011839",
  "marketing_category": "NDA",
  "nonproprietary_name": "medroxyprogesterone acetate",
  "start_marketing_date": "20200720",
  "active_numerator_strength": "10"
}

Related drugs

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