Megestrol Acetate

Orange BookUNIISPLATC L02AB01

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

Identification

ManufacturerXttrium Laboratories, Inc.

CountryUS (United States)

ATC codeL02AB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
0116401108
237 mL in 1 BOTTLE, PLASTIC (0116-4011-08)
ndc11
0116401111
10 TRAY in 1 CASE (0116-4011-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)
ndc11
0116401116
480 mL in 1 BOTTLE, PLASTIC (0116-4011-16)
ndc11
0116401130
30 TRAY in 1 CASE (0116-4011-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)
ndc11
0116401140
40 TRAY in 1 CASE (0116-4011-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0116-4011-10)

Annotations

UNII (FDA Substance ID)

TJ2M0FR8ES

MEGESTROL ACETATE

RxCUI 29451

Orange Book

A076721

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": "0116-4011_3aae2aec-a959-8e66-e063-6294a90a8f46",
  "productndc": "0116-4011",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "076721",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG/ML",
        "product_no": "001",
        "approval_date": "Nov 1, 2004"
      }
    ],
    "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": "ANDA076721",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Megestrol Acetate",
  "start_marketing_date": "20250328",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code L02AB01.

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