FDA.reportPublic FDA data

NDC 59762-0058-01 - 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
59762-0058
Requested NDC
59762-0058-01
Package NDCs from labels
59762-0058-1, 59762-0058-2, 59762-0058-01
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
59762-0058-1medroxyprogesterone acetate100 in 1 BOTTLETABLET10033
59762-0058-2medroxyprogesterone acetate1000 in 1 BOTTLETABLET100033

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0058MEDROXYPROGESTERONE 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
59762-0058-1EA - Each59762-005874824a06-4a73-42ec-9ca7-b0c406fd533512019-01-24
59762-0058-2EA - Each59762-00589b9c7c7c-7cd2-4707-8811-c4144d961d0212020-04-20

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 2 of 11 · 216 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medroxyprogesterone AcetateMEDROXYPROGESTERONE ACETATEPreferred Pharmaceuticals, Inc.37275fd0-eb24-40a4-a93f-b818bb98414e2026-06-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1000114
unii: C2QI4IOI2G
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
unii: T5L8T28FGP
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEMylan Pharmaceuticals Inc.2627eb11-06bf-4a45-9172-094468e3ca072026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA011839
ndc (package): 59762-0058-1
ndc (package): 59762-0058-2
ndc (package): 59762-0056-2
ndc (package): 59762-0055-2
ndc (package): 59762-0055-1
ndc (package): 59762-0056-1
ndc (product): 59762-0058
ndc (product): 59762-0055
ndc (product): 59762-0056
ndc11 (package): 59762005801
rxcui: 1000141
rxcui: 1000114
rxcui: 1000135
spl id: 602a8237-8197-41ce-bfaf-03c6340cbe07
spl set id: 2627eb11-06bf-4a45-9172-094468e3ca07
unii: C2QI4IOI2G
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
unii: T5L8T28FGP
PremproCONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.fd0c0836-5d23-2183-da81-9dc7f42870522026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsExact identifier
unii: T5L8T28FGP
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Equaline HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa6ed1987-37ad-4bfd-8cea-f03426953f5a2026-04-16WarningsExact identifier
unii: T5L8T28FGP
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
HemorrhoidalLIDOCAINE, MINERAL OIL, PHENYLEPHRINE HCL, WHITE PETROLATUMWalgreens Co3d213ba8-3cbe-11c4-e063-6394a90ae0162026-03-30WarningsExact identifier
unii: T5L8T28FGP
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEA-S Medication Solutions5e817926-ba15-4d16-9463-88f6ff3bd3ac2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C2QI4IOI2G
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

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