Medroxyprogesterone

Orange BookUNIISPLATC L02AB02

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

Identification

ManufacturerPharmPak, Inc.

CountryUS (United States)

ATC codeL02AB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5434880505
1 BOTTLE in 1 BOX (54348-805-05) / 5 TABLET in 1 BOTTLE
ndc11
5434880510
1 BOTTLE in 1 BOX (54348-805-10) / 10 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

C2QI4IOI2G

MEDROXYPROGESTERONE ACETATE

RxCUI 1000112

Orange Book

A040159

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": "54348-805_eaa58b56-e846-aab7-e053-2995a90a49c2",
  "productndc": "54348-805",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "040159",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "2.5MG",
        "product_no": "001",
        "approval_date": "Aug 9, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "002",
        "approval_date": "Aug 9, 1996"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "10MG",
        "product_no": "003",
        "approval_date": "Aug 9, 1996"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEDROXYPROGESTERONE ACETATE",
  "proprietary_name": "Medroxyprogesterone",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA040159",
  "marketing_category": "ANDA",
  "nonproprietary_name": "MEDROXYPROGESTERONE",
  "start_marketing_date": "20190712",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code L02AB02.

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