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 1 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Abiraterone AcetateABIRATERONE ACETATEApotex Corp.2ac063f0-4177-c90f-27c3-e70e296892552026-09-03Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
ABIRATERONE ACETATEABIRATERONEAvKAREc1200e4e-c4f7-9067-e053-2a95a90af5092026-08-11Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONE ACETATEGolden State Medical Supply, Inc.58b88e76-eba4-2471-e063-6394a90ad9882026-08-10Warnings, Adverse reactionsExact identifier
application number: ANDA208446
unii: EM5OCB9YJ6
ABIRATERONE ACETATEABIRATERONE ACETATEGolden State Medical Supply, Inc.445e70a1-25bd-8fc1-e063-6394a90a1a432026-06-16Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
YONSAABIRATERONE ACETATESun Pharmaceutical Industries, Inc.b8967e10-f768-47ce-ac9e-2324c83901322026-06-08Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
abiraterone acetateABIRATERONE ACETATENORTHSTAR RX LLC42d5baa8-aca7-49d8-9c24-9d87b707ec202026-05-05Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONE ACETATEAvPAK5108c2fe-9706-c976-e063-6294a90a796d2026-05-04Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONE ACETATEMylan Pharmaceuticals Inc.fe02db79-fa04-441f-b514-70bd74af66242026-04-15Warnings, Adverse reactionsExact identifier
application number: ANDA208446
unii: EM5OCB9YJ6
AbirateroneABIRATERONE ACETATEBluePoint Laboratories32f6b83d-c743-4934-9a20-1b5bf9f4eea32026-03-24Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONE ACETATEMajor Pharmaceuticals49809a29-6558-43a3-a347-5027de44aa412026-03-17Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
abiraterone acetateABIRATERONE ACETATEGlenmark Pharmaceuticals Inc., USAba32c453-a231-452a-a6d9-b3e57afb2e752026-01-30Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONEAvKARE7f82d549-6654-1efd-e053-2991aa0aa28d2026-01-13Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONE ACETATENovugen Pharma (USA) LLCf308b463-27e4-422a-95a2-ecbbf95eee202026-01-07Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
AKEEGANIRAPARIB TOSYLATE MONOHYDRATE AND ABIRATERONE ACETATEJanssen Biotech, Inc.8245a990-3268-4613-b5c5-9537858a1eb92025-12-18Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
AbirateroneABIRATERONE ACETATENovadoz Pharmaceuticals LLC88d05db3-8bdc-47f1-bb00-6b4a71f986092025-11-12Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
AbirateroneABIRATERONE ACETATECivicaScript, LLC0ef857ee-2bfc-4d27-a417-ad58fc3a6ff62025-10-21Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
AbirateroneABIRATERONE ACETATEPD-Rx Pharmaceuticals, Inc.413c645e-074d-4276-b39a-d835210776022025-10-08Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
ZytigaABIRATERONE ACETATEJanssen Biotech, Inc.4e338e89-3cf2-48eb-b6e2-a06c608c65132025-03-28Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6
Abiraterone AcetateABIRATERONE ACETATEDr. Reddys Laboratories Inc0c91aa38-3b0a-232c-8eb1-55f08e8e66442025-03-17Warnings, Adverse reactionsExact identifier
unii: EM5OCB9YJ6

Reported adverse events (FAERS/openFDA)#

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