FDA.reportPublic FDA data

NDC 59762-0055-01 - medroxyprogesterone 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
59762-0055
Requested NDC
59762-0055-01
Package NDCs from labels
59762-0055-1, 59762-0055-2, 59762-0055-01
Manufacturer
Mylan Pharmaceuticals Inc. | Pfizer Inc | Pharmacia & Upjohn Company LLC | Pfizer Italia S.r.l.
Effective date
2026-05-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Medroxyprogesterone Acetate Tablets, USPMylan Pharmaceuticals Inc. | Pfizer Inc | Pharmacia & Upjohn Company LLC | Pfizer Italia S.r.l.2026-05-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0055-1medroxyprogesterone acetate100 in 1 BOTTLETABLET10033
59762-0055-2medroxyprogesterone acetate1000 in 1 BOTTLETABLET100033

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0055MEDROXYPROGESTERONE ACETATE TABLET [MYLAN PHARMACEUTICALS INC.]32Current NDC, Legacy NDC, 2 package rows20250523_2627eb11-06bf-4a45-9172-094468e3ca07.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0055-1EA - Each59762-0055d2be7d54-a65c-4dfa-b74d-dcd83927079812018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LMEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GMEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BMEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
SUCROSEINACTIVE INGREDIENTC151H8M554MEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9
TALCINACTIVE INGREDIENT7SEV7J4R1UMEDROXYPROGESTERONE ACETATE TABLET [GREENSTONE LLC]9

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 7 of 11 · 216 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A-5SUCROSEDNA Labs, Inc.8e63f697-26c1-4518-acd3-5ea72cfa27f72025-01-09WarningsExact identifier
unii: C151H8M554
Medroxyprogesterone Acetate Injectable SuspensionMEDROXYPROGESTERONE ACETATEHikma Pharmaceuticals USA Inc.0476eac5-d96c-4910-aa86-1ddeeefefe502025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Mineral OilMINERAL OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsExact identifier
unii: T5L8T28FGP
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPD-Rx Pharmaceuticals, Inc.437edd12-2c08-4df4-8cf7-64c47e4779ac2025-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000114
unii: C2QI4IOI2G
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
unii: T5L8T28FGP
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
unii: T5L8T28FGP
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: C151H8M554
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
unii: T5L8T28FGP
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
unii: T5L8T28FGP
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
unii: T5L8T28FGP
Dr. Butler Soothing IncontinencePETROLATUM 36%Beyond Health P.A.d17a0c28-a5b7-4df0-e053-2995a90a8edd2024-12-15WarningsExact identifier
unii: T5L8T28FGP
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
unii: T5L8T28FGP
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
unii: T5L8T28FGP
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
unii: T5L8T28FGP
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
unii: T5L8T28FGP
FocusADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUMDeseret Biologicals, Inc.e014e6b6-a07a-4170-b9af-f477da71597d2024-11-13WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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