FDA.reportPublic FDA data

NDC 42292-057-01 - Abiraterone 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
42292-057
Requested NDC
42292-057-01
Package NDCs from labels
42292-057-01, 42292-057-03
Manufacturer
Mylan Institutional Inc.
Effective date
2021-12-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Abiraterone Acetate - Mylan Institutional Inc.Mylan Institutional Inc.2021-12-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42292-057-01EA - Each42292-0572a12e42d-f1c4-4353-8c69-bc76c56844e912020-07-13
42292-057-03EA - Each42292-057544cba86-c958-4cac-b80d-1c9349f2bd3e12020-07-13

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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
AbirtegaABIRATERONE ACETATECivicaScript, LLC2f932015-28b2-4f44-ac04-772e982e13e92025-02-28Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONEAmerican Health Packagingb36bff33-595e-4827-9a73-85c6954c314c2025-02-26Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone acetateABIRATERONE ACETATEFlorida Pharmaceutical Products, LLC68121a71-5024-4f9e-bd9c-2d412f6a63552025-01-12Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
AbirateroneABIRATERONE ACETATEHikma Pharmaceuticals USA Inc.be29365a-ed25-44c0-9818-e9016dc95ba62024-12-20Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
Abiraterone acetateABIRATERONE ACETATERising Pharma Holdings, Inc.54ae5ef9-aea5-484a-a473-863b1397e2062024-09-05Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
AbirateroneABIRATERONE ACETATEQuallent Pharmaceuticals Health LLC6f5b628b-69da-4a04-a4d5-623b18d1fd5d2024-07-16Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 368GB5141J
Abiraterone AcetateABIRATERONE ACETATENorthStar Rx LLC39434b24-bf64-f5c9-fbb6-b0d2250994242023-12-26Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONE ACETATEBryant Ranch Prepack79082b18-adde-4ffb-832a-b8c1d030c4132023-12-07Warnings, Adverse reactionsExact identifier
application number: ANDA208446
unii: EM5OCB9YJ6
abiraterone acetateABIRATERONE ACETATEApotex Corp.9ce9d926-ef3a-4b22-a703-f49c18eb4e3d2023-10-18Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONE ACETATEDr. Reddys Laboratories Inc7eda0d98-c2ba-c117-b757-1f566292e7892023-09-04Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONEAmneal Pharmaceuticals NY LLCc9eb9b46-f847-40a8-802c-a51b40406d5a2023-08-14Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 368GB5141J
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 368GB5141J
abiraterone acetateABIRATERONE ACETATEFlorida Pharmaceutical Products, LLC.b3e7f851-4132-4003-8f14-0eea21e5009c2023-04-28Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 368GB5141J

Reported adverse events (FAERS/openFDA)#

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