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United States · US · US:0548-5410_24f666b3-e168-4860-87d3-bd6c02617ede

Medroxyprogesterone Acetate

Orange BookUNIISPLATC L02AB02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAmphastar Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL02AB02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0548541000
    1 VIAL, SINGLE-DOSE in 1 CARTON (0548-5410-00) / 1 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    0548541025
    25 VIAL, SINGLE-DOSE in 1 CARTON (0548-5410-25) / 1 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
C2QI4IOI2G
MEDROXYPROGESTERONE ACETATE
RxCUI 1000112
Orange Book
A077235
AB
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": "INTRAMUSCULAR",
  "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": "0548-5410_24f666b3-e168-4860-87d3-bd6c02617ede",
  "productndc": "0548-5410",
  "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "077235",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG/ML",
        "product_no": "001",
        "approval_date": "Nov 28, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEDROXYPROGESTERONE ACETATE",
  "proprietary_name": "Medroxyprogesterone Acetate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA077235",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Medroxyprogesterone acetate",
  "start_marketing_date": "20171128",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code L02AB02.

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