CARVEDILOL

Product NDC: 68788-8177
Requested package NDC: 68788-8177-3
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	68788-8177-3	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 108 · 2,158 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	ab8aa773-0ed1-4d59-a1bb-f46cf882644f	2026-07-30	Warnings, Adverse reactions	Exact identifier rxcui: 200033 unii: 0K47UL67F2
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 ndc (package): 72789-431-60 ndc (product): 72789-431 rxcui: 200031 spl id: 57c4f4c8-bf6c-9eef-e063-6394a90ae973 spl set id: 95300809-be15-461e-904e-b56aba676975 unii: 0K47UL67F2
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 ndc (package): 72789-440-90 ndc (package): 72789-440-93 ndc (product): 72789-440 rxcui: 200033 spl id: 57c5a906-6f64-2a6d-e063-6294a90a747a spl set id: 9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa9 unii: 0K47UL67F2
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 ndc (package): 68071-5311-8 ndc (product): 68071-5311 rxcui: 200031 spl id: 574c41aa-6013-2256-e063-6394a90a6fed spl set id: 574c419f-3b9e-2171-e063-6394a90a0e90 unii: 0K47UL67F2
True Coast SPF 50 Mineral Sunscreen	ZINC OXIDE 18%, TITANIUM DIOXIDE 6%	Foshan Sugar Max Cosmetics CO.,Ltd	5379466d-8d14-5fc2-e063-6394a90abd7e	2026-07-22	Warnings	Exact identifier unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	571f23e9-1126-e32d-e063-6294a90a9951	2026-07-21	Warnings	Exact identifier unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREEN	MENS SPF50 ALL IN ONE SUNSCREEN	Lance (Guangzhou) Biological Technology Co., Ltd.	57074480-77fd-cc06-e063-6294a90a28d4	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	5711364c-f9b4-bfa6-e063-6294a90ace4a	2026-07-20	Warnings	Exact identifier unii: 15FIX9V2JP
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	0e98593a-8424-48c8-acc0-671f4b566aee	2026-07-14	Warnings, Adverse reactions	Exact identifier rxcui: 200033 unii: 0K47UL67F2
Bombee Honey Daily Glow Shield Sunscreen	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	ABT ASIA Inc.	56112dff-b091-7a56-e063-6294a90a77d3	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB3 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a233350-729a-1e0c-e063-6394a90ad48c	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB9 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a23f72b-4c33-a100-e063-6294a90ac632	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB10 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a241d80-b9d2-ea93-e063-6294a90ab366	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB8 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a23f728-a824-48a6-e063-6394a90acae7	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB4 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a23653a-2481-bd15-e063-6394a90a7133	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB5 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a238f2d-efa9-01d1-e063-6294a90aae6f	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB1 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a2105a7-6ae8-ed6e-e063-6394a90a3d07	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB2 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a22c1c6-912a-7222-e063-6294a90a5406	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB7 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a23b531-ac53-f0df-e063-6294a90afcf9	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB6 01	ZINC OXIDE, TITANIUM DIOXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	4a23c619-e925-392c-e063-6394a90af5a4	2026-07-08	Warnings	Exact identifier unii: 15FIX9V2JP

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
68788-8177-3	68788817703	30 TABLET, FILM COATED in 1 BOTTLE (68788-8177-3)	2022-04-28	0000-00-00	No	No	Current