Abiraterone Acetate

Product NDC: 51407-181
Requested package NDC: 51407-181-12
11-digit product format: 514070181
Labeler code: 51407
Product ID: 51407-181_e0cf4bd0-c435-b422-e053-2995a90a62e1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: abiraterone acetate
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA208446
Marketing category: ANDA
Marketing start: 2018-10-31
Marketing end: 0000-00-00
Substance: ABIRATERONE ACETATE
Active strength: 250 mg/1
Pharmacologic classes: Cytochrome P450 17A1 Inhibitor [EPC], Cytochrome P450 17A1 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51407-181	51407-181-12	D	Discontinued by firm		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208446-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2018-10-31
A208446-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2020-12-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208446-001	AB
A208446-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A208446-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2018-10-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208446-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2020-12-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A208446-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A208446-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abiraterone Acetate	ABIRATERONE ACETATE	Mylan Pharmaceuticals Inc.	fe02db79-fa04-441f-b514-70bd74af6624	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208446 application number: ANDA208446
Abiraterone Acetate	ABIRATERONE ACETATE	Bryant Ranch Prepack	79082b18-adde-4ffb-832a-b8c1d030c413	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208446 application number: ANDA208446

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-181-12	EA - Each	51407-181	71f37eb1-e78a-4d84-aaea-54d3e8206528	1	2019-02-13

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EM5OCB9YJ6	ABIRATERONE ACETATE	154229-18-2	ABIRATERONE ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-181-12	51407018112	120 TABLET in 1 BOTTLE, PLASTIC (51407-181-12)	120 tablet	2019-01-16	0000-00-00	No	No	Current