CARVEDILOL

Product NDC: 68788-8177
Requested package NDC: 68788-8177-6
11-digit product format: 687888177
Labeler code: 68788
Product ID: 68788-8177_29e5b8be-74c1-46de-8c6a-ec1950594a71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARVEDILOL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA078165
Marketing category: ANDA
Marketing start: 2022-04-28
Marketing end: 0000-00-00
Substance: CARVEDILOL
Active strength: 6 mg/1
Pharmacologic classes: Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]
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	68788-8177	68788-8177-6	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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078165-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A078165-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A078165-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A078165-004	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078165-001	AB
A078165-002	AB
A078165-003	AB
A078165-004	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A078165-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078165-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078165-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078165-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`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	A078165-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078165-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078165-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A078165-004	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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CARVEDILOL	CARVEDILOL	PD-Rx Pharmaceuticals, Inc.	95300809-be15-461e-904e-b56aba676975	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	PD-Rx Pharmaceuticals, Inc.	9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa9	2026-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	NuCare Pharmaceuticals, Inc.	574c419f-3b9e-2171-e063-6394a90a0e90	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	03b7c07c-14ba-40c8-8c0a-8dfa4a10f580	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	fe462198-32ae-4f6c-befc-acb97fb017c9	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	Bryant Ranch Prepack	1ddff189-1848-4186-bca9-063e4ea7fd1f	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	NuCare Pharmaceuticals, Inc.	4bbf3767-8666-22d8-e063-6294a90a2afe	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	Advagen Pharma Ltd	7a7d3ca1-05b0-4c7e-aefa-492cc441585d	2026-02-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	A-S Medication Solutions	5eeeaeee-9698-493f-9aa7-d13068147208	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	A-S Medication Solutions	947baca7-f9c8-4821-b47b-53c45288613e	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	Preferred Pharmaceuticals Inc.	8d3937b4-e0dd-4165-9825-bbf5020d79f9	2025-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	RedPharm Drug, Inc	fcb1de7c-1878-1835-e053-6294a90abe95	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165
CARVEDILOL	CARVEDILOL	RedPharm Drug, Inc	fcb2025f-11a1-ea73-e053-6394a90a61cb	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078165 application number: ANDA078165

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8177-3	EA - Each	68788-8177	724a4ee2-bc2c-4d4c-901a-5d5e66a98960	1	2022-07-06
68788-8177-6	EA - Each	68788-8177	a660a2d2-7dab-4246-a070-6a8907823cff	1	2022-07-06
68788-8177-9	EA - Each	68788-8177	6a678876-0007-4500-bea8-df257ac95bdc	1	2022-07-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K47UL67F2	CARVEDILOL	72956-09-3	CARVEDILOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8177-6	68788817706	60 TABLET, FILM COATED in 1 BOTTLE (68788-8177-6)	2022-04-28	0000-00-00	No	No	Current