medroxyprogesterone acetate

Orange BookUNIISPLATC L02AB02

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

Identification

ManufacturerMylan Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL02AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5976200581
100 TABLET in 1 BOTTLE (59762-0058-1)
ndc11
5976200582
1000 TABLET in 1 BOTTLE (59762-0058-2)

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": {
    "1020bb60-4f13-4cd7-aaa1-c556752c84b7": {
      "match": "brand_token",
      "title": "MEDROXYPROGESTERONE ACETATE TABLET [REMEDYREPACK INC.]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "59762-0058_602a8237-8197-41ce-bfaf-03c6340cbe07",
  "productndc": "59762-0058",
  "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": "medroxyprogesterone acetate",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA011839",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "medroxyprogesterone acetate",
  "start_marketing_date": "20180820",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code L02AB02.

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