megestrol acetate

Generic: megestrol acetate

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name megestrol acetate
Generic Name megestrol acetate
Labeler strides pharma science limited
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

megestrol acetate 40 mg/mL

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-160
Product ID 64380-160_d842f1ed-8df5-4fe9-a694-5da7a042134e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075671
Listing Expiration 2026-12-31
Marketing Start 2022-03-21

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380160
Hyphenated Format 64380-160

Supplemental Identifiers

RxCUI
860225
UPC
0364380160014
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 ANDA075671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE, PLASTIC (64380-160-01)
  • 480 mL in 1 BOTTLE, PLASTIC (64380-160-02)
source: ndc

Packages (2)

64380-160-01 240 mL in 1 BOTTLE, PLASTIC (64380-160-01) 64380-160-02 480 mL in 1 BOTTLE, PLASTIC (64380-160-02)

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": "d842f1ed-8df5-4fe9-a694-5da7a042134e", "openfda": {"upc": ["0364380160014"], "unii": ["TJ2M0FR8ES"], "rxcui": ["860225"], "spl_set_id": ["9f7365a0-67cf-45fc-a914-e40a4507a063"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "240 mL in 1 BOTTLE, PLASTIC (64380-160-01)", "package_ndc": "64380-160-01", "marketing_start_date": "20220321"}, {"sample": false, "description": "480 mL in 1 BOTTLE, PLASTIC (64380-160-02)", "package_ndc": "64380-160-02", "marketing_start_date": "20220321"}], "brand_name": "Megestrol Acetate", "product_id": "64380-160_d842f1ed-8df5-4fe9-a694-5da7a042134e", "dosage_form": "SUSPENSION", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "64380-160", "generic_name": "Megestrol Acetate", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Megestrol Acetate", "active_ingredients": [{"name": "MEGESTROL ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA075671", "marketing_category": "ANDA", "marketing_start_date": "20220321", "listing_expiration_date": "20261231"}