megestrol acetate

Generic: megestrol acetate

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name megestrol acetate
Generic Name megestrol acetate
Labeler pai holdings, llc dba pai pharma
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

megestrol acetate 400 mg/10mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1038
Product ID 0121-1038_5dbcf915-968f-4377-b56f-8ef863e398ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077404
Listing Expiration 2026-12-31
Marketing Start 2025-10-17

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211038
Hyphenated Format 0121-1038

Supplemental Identifiers

RxCUI
860225
UNII
TJ2M0FR8ES

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name megestrol acetate (source: ndc)
Generic Name megestrol acetate (source: ndc)
Application Number ANDA077404 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/10mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-1038-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)
  • 4 TRAY in 1 CASE (0121-1038-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)
source: ndc

Packages (2)

0121-1038-00 10 TRAY in 1 CASE (0121-1038-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10) 0121-1038-40 4 TRAY in 1 CASE (0121-1038-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)

Ingredients (1)

megestrol acetate (400 mg/10mL)

Linked Drug Pages (1)

Megestrol Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5dbcf915-968f-4377-b56f-8ef863e398ca", "openfda": {"unii": ["TJ2M0FR8ES"], "rxcui": ["860225"], "spl_set_id": ["2d5b58cd-cbb1-4f5c-b13f-63185c0f8e31"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-1038-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)", "package_ndc": "0121-1038-00", "marketing_start_date": "20251017"}, {"sample": false, "description": "4 TRAY in 1 CASE (0121-1038-40)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1038-10)", "package_ndc": "0121-1038-40", "marketing_start_date": "20251017"}], "brand_name": "Megestrol Acetate", "product_id": "0121-1038_5dbcf915-968f-4377-b56f-8ef863e398ca", "dosage_form": "SUSPENSION", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0121-1038", "generic_name": "Megestrol Acetate", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Megestrol Acetate", "active_ingredients": [{"name": "MEGESTROL ACETATE", "strength": "400 mg/10mL"}], "application_number": "ANDA077404", "marketing_category": "ANDA", "marketing_start_date": "20251017", "listing_expiration_date": "20261231"}