FDA.reportPublic FDA data

NDC 59762-4538-9 - 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
59762-4538
Requested NDC
59762-4538-9
Package NDCs from labels
59762-4538-2, 59762-4538-9
Manufacturer
Greenstone LLC | Pfizer Manufacturing Belgium NV | Pharmacia & Upjohn Company LLC
Effective date
2024-08-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
medroxyprogesterone acetate - Greenstone LLC | Pfizer Manufacturing Belgium NV | Pharmacia & Upjohn Company LLCGreenstone LLC | Pfizer Manufacturing Belgium NV | Pharmacia & Upjohn Company LLC2024-08-16HUMAN PRESCRIPTION DRUG LABEL
medroxyprogesterone acetate - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL
medroxyprogesterone acetate - REMEDYREPACK INC.REMEDYREPACK INC.2021-06-22HUMAN PRESCRIPTION DRUG LABEL
medroxyprogesterone acetate - REMEDYREPACK INC.REMEDYREPACK INC.2018-08-14HUMAN 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
59762-4538-1ML - Milliliter59762-453806ffa173-f68e-405d-8dd0-78eaa2e3dd4412013-03-03
59762-4538-2ML - Milliliter59762-4538982417ac-cda6-4015-b1ff-27c2f928654812013-02-13
59762-4538-9ML - Milliliter59762-45385de51187-690f-4cc2-91be-66867b817d9712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
WATERINACTIVE INGREDIENT059QF0KO0RMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [GREENSTONE LLC]17
MEDROXYPROGESTERONE ACETATEACTIVE INGREDIENTC2QI4IOI2GMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
MEDROXYPROGESTERONEACTIVE MOIETYHSU1C9YRESMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3
WATERINACTIVE INGREDIENT059QF0KO0RMEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [REMEDYREPACK INC. ]3

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 60 · 1,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-08-27WarningsExact identifier
unii: G2M7P15E5P
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
medroxyprogesterone acetateMEDROXYPROGESTERONE ACETATEPrasco Laboratories987496bf-b4b0-409b-b745-f52ed0871f4e2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020246
rxcui: 1000153
unii: C2QI4IOI2G
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
unii: 451W47IQ8X
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 451W47IQ8X
Depo-ProveraMEDROXYPROGESTERONE ACETATEPharmacia & Upjohn Company LLC199cf13e-0859-4a73-9b45-e700d0cd10492026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020246
rxcui: 1000153
unii: C2QI4IOI2G
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: 451W47IQ8X
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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