FDA.reportPublic FDA data

NDC 0555-0607-04 - 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
0555-0607
Requested NDC
0555-0607-04
Package NDCs from labels
0555-0607-02, 0555-0607-04
Manufacturer
Bryant Ranch Prepack
Effective date
2025-01-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Megestrol Acetate - Bryant Ranch PrepackBryant Ranch Prepack2025-01-17HUMAN PRESCRIPTION DRUG LABEL
Megestrol Acetate Tablets, USP Rx onlyTeva Pharmaceuticals USA, Inc.2022-11-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-0607-02Megestrol Acetate100 in 1 BOTTLETABLET10012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0607MEGESTROL ACETATE TABLET [TEVA PHARMACEUTICALS USA, INC.]12Current NDC, Legacy NDC, 1 package rows20250119_66573d39-f2a7-49fd-9ed2-97ac8f6e8456.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0607-02EA - Each0555-0607a11adede-d92f-4882-8273-bf73c794be2c12013-02-13
0555-0607-04EA - Each0555-06076c559447-57ba-402c-82d1-efa74aae2da812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEGESTROL ACETATEACTIVE INGREDIENTTJ2M0FR8ESMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
MEGESTROLACTIVE MOIETYEA6LD1M70MMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MEGESTROL ACETATE TABLET [BARR LABORATORIES INC.]5

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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Megestrol AcetateMEGESTROL ACETATEANI Pharmaceuticals, Inc.a26dcd78-ad62-4cf5-ad97-49ccb34d43ba2024-03-20Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATETeva Pharmaceuticals USA, Inc.66573d39-f2a7-49fd-9ed2-97ac8f6e84562022-11-30Warnings, Adverse reactionsExact identifier
application number: ANDA074621
ndc (package): 0555-0606-02
ndc (package): 0555-0607-02
ndc (product): 0555-0607
ndc (product): 0555-0606
rxcui: 860215
rxcui: 860221
spl id: 6f22887e-a442-4505-bd99-00042e4075c7
spl set id: 66573d39-f2a7-49fd-9ed2-97ac8f6e8456
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEStrides Pharma Science Limited9f7365a0-67cf-45fc-a914-e40a4507a0632022-04-22Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES
Megestrol AcetateMEGESTROL ACETATEProficient Rx LP6342df31-afce-4deb-b992-e08e2a4b2b772022-04-01Warnings, Adverse reactionsExact identifier
unii: TJ2M0FR8ES

Reported adverse events (FAERS/openFDA)#

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