FDA.reportPublic FDA data

NDC 51079-434-01 - 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
51079-434
Requested NDC
51079-434-01
Package NDCs from labels
51079-434-01, 51079-434-20
Manufacturer
Mylan Institutional Inc.
Effective date
2019-11-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Megestrol Acetate Tablets USP Rx onlyMylan Institutional Inc.2019-11-06HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-434-01EA - Each51079-43472ebef1a-3959-4456-ac59-efcb287ffcf612012-07-24
51079-434-20EA - Each51079-43478eb4639-f6b9-4bad-b3d0-99bc6838f64d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEGESTROL ACETATEACTIVE INGREDIENTTJ2M0FR8ESMEGESTROL ACETATE TABLET [MYLAN INSTITUTIONAL INC.]2
MEGESTROLACTIVE MOIETYEA6LD1M70MMEGESTROL ACETATE TABLET [MYLAN INSTITUTIONAL INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMEGESTROL ACETATE TABLET [MYLAN INSTITUTIONAL INC.]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPMEGESTROL ACETATE TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEGESTROL ACETATE TABLET [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEGESTROL ACETATE TABLET [MYLAN INSTITUTIONAL INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEGESTROL ACETATE TABLET [MYLAN INSTITUTIONAL INC.]2

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 · 25 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
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPreferred Pharmaceuticals Inc.edef65d1-d583-4cee-bb9a-515be84ac51d2026-06-15Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEUpsher-Smith Laboratories, LLC2dc921d5-e423-4379-a345-151e87d136512026-04-14Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49e5eeaa-7506-f42a-e063-6294a90a28642026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f94296-3e74-1828-e063-6394a90a97d52026-02-03WarningsExact identifier
unii: O7TSZ97GEP
BIS II ToothPRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINIUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATEJewoo Medical CO.,LTD49f942e6-ceef-5505-e063-6394a90a113f2026-02-03WarningsExact identifier
unii: O7TSZ97GEP
Megestrol AcetateMEGESTROL ACETATEMajor Pharmaceuticalse44cf173-991b-43cf-93f2-e0efaa4cc29a2026-01-15Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATENatco Pharma USA LLC582cff8a-1def-43d6-ba7e-dce49e3e9f272026-01-15Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEAmerican Health Packaging2921731a-6866-4dc8-8f6b-b636abf7bcf82026-01-05Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPAI Holdings, LLC dba PAI Pharma2d5b58cd-cbb1-4f5c-b13f-63185c0f8e312025-10-17Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEMajor Pharmaceuticals2c755c6b-32e9-4029-8b70-855007f7375b2025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 860221
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEKesin Pharma Corporation3bc8708e-a52d-fda2-e063-6294a90a0fbc2025-09-02Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEXttrium Laboratories, Inc.3169f883-4076-32ce-e063-6394a90a49252025-07-24Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEBryant Ranch Prepackdd6617df-0876-4fc5-8435-b53d29ccc1ae2025-03-31Warnings, Adverse reactionsExact identifier
rxcui: 860221
unii: TJ2M0FR8ES
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Megestrol AcetateMEGESTROL ACETATEStrides Pharma Science Limited8ec70070-da70-4a38-9d58-cf22785176612025-02-24Warnings, Adverse reactionsExact identifier
rxcui: 860215
rxcui: 860221
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEBryant Ranch Prepack9b764cf3-4756-4f0e-b747-421d716743132025-01-17Warnings, Adverse reactionsExact identifier
application number: ANDA074621
rxcui: 860221
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEGolden State Medical Supply, Inc.19c33213-7919-208d-e063-6394a90a0f082024-05-31Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPrecision Dose Inc.bf0d54c5-b813-4f2e-9a37-cbea332cfe532024-03-28Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEPrecision Dose Inc.d0ad931e-4e3e-48bf-9949-77d6971da6e62024-03-28Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES

Reported adverse events (FAERS/openFDA)#

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