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United States · US · US:0555-0606_6f22887e-a442-4505-bd99-00042e4075c7

Megestrol Acetate

Orange BookUNIISPLATC L02AB01

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

Identification

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

Packs · 1

  • ndc11
    0555060602
    100 TABLET in 1 BOTTLE (0555-0606-02)

Annotations

UNII (FDA Substance ID)
TJ2M0FR8ES
MEGESTROL ACETATE
RxCUI 29451
Orange Book
A074621
ABAB
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": "0555-0606_6f22887e-a442-4505-bd99-00042e4075c7",
  "productndc": "0555-0606",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "074621",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "001",
        "approval_date": "Nov 30, 1995"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Aug 16, 1996"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MEGESTROL ACETATE",
  "proprietary_name": "Megestrol Acetate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA074621",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Megestrol Acetate",
  "start_marketing_date": "19961025",
  "active_numerator_strength": "20"
}

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