megestrol acetate

Generic: megestrol acetate

Labeler: ani pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

megestrol acetate 40 mg/mL

Manufacturer
ANI Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70954-896
Product ID 70954-896_a26dcd78-ad62-4cf5-ad97-49ccb34d43ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077404
Listing Expiration 2026-12-31
Marketing Start 2024-07-02

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70954896
Hyphenated Format 70954-896

Supplemental Identifiers

RxCUI
860225
UPC
0370954896203
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 ANDA077404 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE (70954-896-10)
  • 480 mL in 1 BOTTLE (70954-896-20)
source: ndc

Packages (2)

70954-896-10 240 mL in 1 BOTTLE (70954-896-10) 70954-896-20 480 mL in 1 BOTTLE (70954-896-20)

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": "a26dcd78-ad62-4cf5-ad97-49ccb34d43ba", "openfda": {"upc": ["0370954896203"], "unii": ["TJ2M0FR8ES"], "rxcui": ["860225"], "spl_set_id": ["a26dcd78-ad62-4cf5-ad97-49ccb34d43ba"], "manufacturer_name": ["ANI Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE (70954-896-10)", "package_ndc": "70954-896-10", "marketing_start_date": "20240702"}, {"sample": false, "description": "480 mL in 1 BOTTLE (70954-896-20)", "package_ndc": "70954-896-20", "marketing_start_date": "20240702"}], "brand_name": "Megestrol Acetate", "product_id": "70954-896_a26dcd78-ad62-4cf5-ad97-49ccb34d43ba", "dosage_form": "SUSPENSION", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "70954-896", "generic_name": "Megestrol Acetate", "labeler_name": "ANI Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Megestrol Acetate", "active_ingredients": [{"name": "MEGESTROL ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA077404", "marketing_category": "ANDA", "marketing_start_date": "20240702", "listing_expiration_date": "20261231"}