Carvedilol

Product NDC: 71335-1128
11-digit product format: 713351128
Labeler code: 71335
Product ID: 71335-1128_06540a82-d48f-46df-bf2c-04e8332ba9ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078251
Marketing category: ANDA
Marketing start: 2007-09-05
Substance: CARVEDILOL
Active strength: 3.125 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: 2026-12-31
Current FDA listing: Yes

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
A078251-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A078251-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A078251-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A078251-004	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
A078251-001	AB
A078251-002	AB
A078251-003	AB
A078251-004	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.

Product history page 1 of 5 · 164 observed 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
2026-02-19 14:30 UTC	2026-02	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078251-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078251-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078251-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078251-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078251-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078251-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078251-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078251-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078251-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078251-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078251-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078251-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078251-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078251-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carvedilol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARVEDILOL	3.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K47UL67F2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200032	Internal RxNorm lookup
200033	Internal RxNorm lookup
686924	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b4e700f8-d0e0-4ad5-93b5-e935389a96e3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e148a93c-bfff-2735-e6c0-0739297b4596	Product name	3	20180705
32d6365f-9f0e-0782-b719-48e651893fb7	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1128-1	Carvedilol	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
71335-1128-2	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100	9
71335-1128-3	Carvedilol	180 in 1 BOTTLE	TABLET, FILM COATED	180	9
71335-1128-4	Carvedilol	60 in 1 BOTTLE	TABLET, FILM COATED	60	9
71335-1128-5	Carvedilol	90 in 1 BOTTLE	TABLET, FILM COATED	90	9
71335-1128-6	Carvedilol	120 in 1 BOTTLE	TABLET, FILM COATED	120	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1128	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	9	Current NDC, Legacy NDC, 6 package rows	20231209_b4e700f8-d0e0-4ad5-93b5-e935389a96e3.zip

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 1 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Major Pharmaceuticals	ec6d8d73-9d18-4a9e-ae0c-0ea12059e78e	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251 ndc (product): 71335-1128
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	d7669550-adcc-4e70-83b1-c28ce75e7fda	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Cardinal Health 107, LLC	bd0f2596-a192-4b0e-836f-4a09816408a4	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	e285434f-d831-b6e7-e053-2995a90a1ab2	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	84ee5fbf-7299-4b8a-e053-2a91aa0aa159	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	A-S Medication Solutions	ee848543-12fb-446c-86db-bf2322ec986f	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	A-S Medication Solutions	3c8d54e6-835c-4fa7-b13b-b798916cfed3	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	c133b9c7-ab1a-e517-e053-2995a90a517a	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Glenmark Pharmaceuticals Inc., USA	c4a21f67-7812-4634-beba-f8e85c63c5f2	2025-10-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	A-S Medication Solutions	e0ae5bed-1cb4-45d6-befe-dfc68edb9b34	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251
Carvedilol	CARVEDILOL	Proficient Rx LP	c03bd9d7-1e0b-49da-a14a-32e712dc3a2d	2021-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078251 application number: ANDA078251

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200032	carvedilol 12.5 MG Oral Tablet	PSN	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
200033	carvedilol 25 MG Oral Tablet	PSN	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
686924	carvedilol 3.125 MG Oral Tablet	PSN	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
200032	carvedilol 12.5 MG Oral Tablet	SCD	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
200033	carvedilol 25 MG Oral Tablet	SCD	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9
686924	carvedilol 3.125 MG Oral Tablet	SCD	b4e700f8-d0e0-4ad5-93b5-e935389a96e3	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1128-1	71335112801	30 TABLET, FILM COATED in 1 BOTTLE (71335-1128-1)	2019-03-12	0000-00-00	No	No	Current
71335-1128-2	71335112802	100 TABLET, FILM COATED in 1 BOTTLE (71335-1128-2)	2019-03-12	0000-00-00	No	No	Current
71335-1128-3	71335112803	180 TABLET, FILM COATED in 1 BOTTLE (71335-1128-3)	2019-03-12	0000-00-00	No	No	Current
71335-1128-4	71335112804	60 TABLET, FILM COATED in 1 BOTTLE (71335-1128-4)	2019-03-12	0000-00-00	No	No	Current
71335-1128-5	71335112805	90 TABLET, FILM COATED in 1 BOTTLE (71335-1128-5)	2019-03-12	0000-00-00	No	No	Current
71335-1128-6	71335112806	120 TABLET, FILM COATED in 1 BOTTLE (71335-1128-6)	2019-03-12	0000-00-00	No	No	Current