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United States · US · US:70954-896_a26dcd78-ad62-4cf5-ad97-49ccb34d43ba

Megestrol Acetate

Orange BookUNIISPLATC L02AB01

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

Identification

ManufacturerANI Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeL02AB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7095489610
    240 mL in 1 BOTTLE (70954-896-10)
  • ndc11
    7095489620
    480 mL in 1 BOTTLE (70954-896-20)

Annotations

UNII (FDA Substance ID)
TJ2M0FR8ES
MEGESTROL ACETATE
RxCUI 29451
Orange Book
A077404
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TJ2M0FR8ES",
    "rxcui": "29451",
    "inchikey": "RQZAXGRLVPAYTJ-GQFGMJRRSA-N",
    "display_name": "MEGESTROL ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2dc921d5-e423-4379-a345-151e87d13651": {
      "match": "brand_token",
      "title": "MEGESTROL ACETATE SUSPENSION [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "19",
      "published_date": "2026-05-01"
    }
  },
  "productid": "70954-896_a26dcd78-ad62-4cf5-ad97-49ccb34d43ba",
  "productndc": "70954-896",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "077404",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Feb 16, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEGESTROL ACETATE",
  "proprietary_name": "Megestrol Acetate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA077404",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Megestrol Acetate",
  "start_marketing_date": "20240702",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code L02AB01.

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