megestrol acetate

Generic: megestrol acetate

Labeler: xttrium laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name megestrol acetate
Generic Name megestrol acetate
Labeler xttrium laboratories, inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

megestrol acetate 40 mg/mL

Manufacturer
Xttrium Laboratories, Inc.

Identifiers & Regulatory

Product NDC 0116-4011
Product ID 0116-4011_3aae2aec-a959-8e66-e063-6294a90a8f46
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076721
Listing Expiration 2026-12-31
Marketing Start 2025-03-28

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01164011
Hyphenated Format 0116-4011

Supplemental Identifiers

RxCUI
860225
UNII
TJ2M0FR8ES

Packaging Origin

Original Packager
true

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 ANDA076721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE, PLASTIC (0116-4011-08)
  • 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)
  • 480 mL in 1 BOTTLE, PLASTIC (0116-4011-16)
  • 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)
  • 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)
source: ndc

Packages (5)

0116-4011-08 237 mL in 1 BOTTLE, PLASTIC (0116-4011-08) 0116-4011-11 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) 0116-4011-16 480 mL in 1 BOTTLE, PLASTIC (0116-4011-16) 0116-4011-30 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) 0116-4011-40 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)

Ingredients (1)

megestrol acetate (40 mg/mL)

Linked Drug Pages (1)

Megestrol Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3aae2aec-a959-8e66-e063-6294a90a8f46", "openfda": {"unii": ["TJ2M0FR8ES"], "rxcui": ["860225"], "spl_set_id": ["3169f883-4076-32ce-e063-6394a90a4925"], "manufacturer_name": ["Xttrium Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (0116-4011-08)", "package_ndc": "0116-4011-08", "marketing_start_date": "20250328"}, {"sample": false, "description": "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)", "package_ndc": "0116-4011-11", "marketing_start_date": "20250328"}, {"sample": false, "description": "480 mL in 1 BOTTLE, PLASTIC (0116-4011-16)", "package_ndc": "0116-4011-16", "marketing_start_date": "20250328"}, {"sample": false, "description": "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)", "package_ndc": "0116-4011-30", "marketing_start_date": "20250328"}, {"sample": false, "description": "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)", "package_ndc": "0116-4011-40", "marketing_start_date": "20250328"}], "brand_name": "Megestrol Acetate", "product_id": "0116-4011_3aae2aec-a959-8e66-e063-6294a90a8f46", "dosage_form": "SUSPENSION", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "0116-4011", "generic_name": "Megestrol Acetate", "labeler_name": "Xttrium Laboratories, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Megestrol Acetate", "active_ingredients": [{"name": "MEGESTROL ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA076721", "marketing_category": "ANDA", "marketing_start_date": "20250328", "listing_expiration_date": "20261231"}