FDA.reportPublic FDA data

NDC 0904-7577-66 - Megestrol Acetate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0904-7577
Requested NDC
0904-7577-66
Package NDCs from labels
0904-7577-66, 0904-7577-72, 0904-7577-18
Manufacturer
Major Pharmaceuticals
Effective date
2026-01-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Megestrol Acetate - Major PharmaceuticalsMajor Pharmaceuticals2026-01-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7577-18Megestrol Acetate4 in 1 CASESUSPENSION42
0904-7577-18Megestrol Acetate10 in 1 TRAYSUSPENSION102
0904-7577-66Megestrol Acetate10 mL in 1 CUP, UNIT-DOSESUSPENSION102
0904-7577-72Megestrol Acetate10 in 1 TRAYSUSPENSION102
0904-7577-72Megestrol Acetate10 in 1 CASESUSPENSION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7577-18ML - Milliliter0904-7577428b9fa4-ee7e-4a59-b922-17074597758712026-02-05
0904-7577-66ML - Milliliter0904-757791989707-c7e8-4371-8dda-fec52a69876812026-02-05
0904-7577-72ML - Milliliter0904-7577a5a455d8-6bba-44fb-864c-5fa3173e1f3812026-02-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Megestrol AcetateMEGESTROL ACETATEATLANTIC BIOLOGICALS CORP.01119031-9943-4afb-8b45-cb71682f04822026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPreferred Pharmaceuticals Inc.edef65d1-d583-4cee-bb9a-515be84ac51d2026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEUpsher-Smith Laboratories, LLC2dc921d5-e423-4379-a345-151e87d136512026-04-14Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEMajor Pharmaceuticalse44cf173-991b-43cf-93f2-e0efaa4cc29a2026-01-15Warnings, Adverse reactionsExact identifier
application number: ANDA077404
ndc (package): 0904-7577-66
ndc (package): 0904-7577-72
ndc (package): 0904-7577-18
ndc (product): 0904-7577
ndc11 (package): 00904757766
rxcui: 860225
spl id: 1843fe79-7628-4f8e-9b51-e0be7562e43d
spl set id: e44cf173-991b-43cf-93f2-e0efaa4cc29a
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATENatco Pharma USA LLC582cff8a-1def-43d6-ba7e-dce49e3e9f272026-01-15Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEAmerican Health Packaging2921731a-6866-4dc8-8f6b-b636abf7bcf82026-01-05Warnings, Adverse reactionsExact identifier
application number: ANDA077404
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPAI Holdings, LLC dba PAI Pharma2d5b58cd-cbb1-4f5c-b13f-63185c0f8e312025-10-17Warnings, Adverse reactionsExact identifier
application number: ANDA077404
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEMajor Pharmaceuticals2c755c6b-32e9-4029-8b70-855007f7375b2025-09-15Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEKesin Pharma Corporation3bc8708e-a52d-fda2-e063-6294a90a0fbc2025-09-02Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEXttrium Laboratories, Inc.3169f883-4076-32ce-e063-6394a90a49252025-07-24Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEBryant Ranch Prepackdd6617df-0876-4fc5-8435-b53d29ccc1ae2025-03-31Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEStrides Pharma Science Limited8ec70070-da70-4a38-9d58-cf22785176612025-02-24Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPAI Holdings, LLC dba PAI Pharma46622697-2c51-44d5-9f1f-e48f8526f1322025-02-07Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEBryant Ranch Prepack9b764cf3-4756-4f0e-b747-421d716743132025-01-17Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEGolden State Medical Supply, Inc.19c33213-7919-208d-e063-6394a90a0f082024-05-31Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPrecision Dose Inc.bf0d54c5-b813-4f2e-9a37-cbea332cfe532024-03-28Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPrecision Dose Inc.d0ad931e-4e3e-48bf-9949-77d6971da6e62024-03-28Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEANI Pharmaceuticals, Inc.a26dcd78-ad62-4cf5-ad97-49ccb34d43ba2024-03-20Warnings, Adverse reactionsExact identifier
application number: ANDA077404
ndc (product): 70954-896
rxcui: 860225
spl id: a26dcd78-ad62-4cf5-ad97-49ccb34d43ba
spl set id: a26dcd78-ad62-4cf5-ad97-49ccb34d43ba
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATETeva Pharmaceuticals USA, Inc.66573d39-f2a7-49fd-9ed2-97ac8f6e84562022-11-30Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEStrides Pharma Science Limited9f7365a0-67cf-45fc-a914-e40a4507a0632022-04-22Warnings, Adverse reactionsExact identifier
rxcui: 860225
unii: TJ2M0FR8ES

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.