megestrol acetate

Generic: megestrol acetate

Labeler: precision dose inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name megestrol acetate
Generic Name megestrol acetate
Labeler precision dose inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

megestrol acetate 40 mg/mL

Manufacturer
Precision Dose Inc.

Identifiers & Regulatory

Product NDC 68094-063
Product ID 68094-063_46a043c6-0099-4723-bbf9-4591a72738fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075671
Listing Expiration 2026-12-31
Marketing Start 2022-07-11

Pharmacologic Class

Classes
progesterone congeners [cs] progestin [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68094063
Hyphenated Format 68094-063

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 ANDA075671 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (68094-063-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-063-59)
  • 3 TRAY in 1 CASE (68094-063-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-063-59)
source: ndc

Packages (2)

68094-063-61 10 TRAY in 1 CASE (68094-063-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-063-59) 68094-063-62 3 TRAY in 1 CASE (68094-063-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-063-59)

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": "46a043c6-0099-4723-bbf9-4591a72738fd", "openfda": {"unii": ["TJ2M0FR8ES"], "rxcui": ["860225"], "spl_set_id": ["d0ad931e-4e3e-48bf-9949-77d6971da6e6"], "manufacturer_name": ["Precision Dose Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (68094-063-61)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-063-59)", "package_ndc": "68094-063-61", "marketing_start_date": "20220711"}, {"sample": false, "description": "3 TRAY in 1 CASE (68094-063-62)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (68094-063-59)", "package_ndc": "68094-063-62", "marketing_start_date": "20220711"}], "brand_name": "Megestrol Acetate", "product_id": "68094-063_46a043c6-0099-4723-bbf9-4591a72738fd", "dosage_form": "SUSPENSION", "pharm_class": ["Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68094-063", "generic_name": "Megestrol Acetate", "labeler_name": "Precision Dose Inc.", "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": "20220711", "listing_expiration_date": "20261231"}