Carvedilol

Product NDC: 65841-616
11-digit product format: 658410616
Labeler code: 65841
Product ID: 65841-616_98f78a02-849a-4540-85f8-f0ea1eb1f8f1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA077614
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A077614-001	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A077614-002	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A077614-003	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05
A077614-004	CARVEDILOL	CARVEDILOL	3.125MG	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
A077614-001	AB
A077614-002	AB
A077614-003	AB
A077614-004	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 · 172 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
2026-09-14 22:38:34	2026-08	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077614-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077614-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077614-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077614-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077614-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077614-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077614-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077614-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077614-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077614-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077614-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077614-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077614-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077614-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200031	Internal RxNorm lookup
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
29082d8c-bbde-4620-924f-02dcf1764919	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
65841-616-01	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100	10
65841-616-05	Carvedilol	500 in 1 BOTTLE	TABLET, FILM COATED	500	10
65841-616-17	Carvedilol	28 in 1 BOTTLE	TABLET, FILM COATED	28	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-616	CARVEDILOL TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	9	Current NDC, Legacy NDC, 3 package rows	20241128_29082d8c-bbde-4620-924f-02dcf1764919.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 3 of 3 · 45 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	da830b08-1cdd-4d36-a068-c376fd7763c4	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Proficient Rx LP	0bfea06d-7abe-407a-80a4-d15d373569f7	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	e31271aa-259b-caa6-e053-2995a90a0fcd	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	8ccf07f5-78fb-76da-e053-2a95a90a0090	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals, Inc.	49afdf89-0bed-71da-e054-00144ff88e88	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614

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	29082d8c-bbde-4620-924f-02dcf1764919	10
200033	carvedilol 25 MG Oral Tablet	PSN	29082d8c-bbde-4620-924f-02dcf1764919	10
686924	carvedilol 3.125 MG Oral Tablet	PSN	29082d8c-bbde-4620-924f-02dcf1764919	10
200031	carvedilol 6.25 MG Oral Tablet	PSN	29082d8c-bbde-4620-924f-02dcf1764919	10
200032	carvedilol 12.5 MG Oral Tablet	SCD	29082d8c-bbde-4620-924f-02dcf1764919	10
200033	carvedilol 25 MG Oral Tablet	SCD	29082d8c-bbde-4620-924f-02dcf1764919	10
686924	carvedilol 3.125 MG Oral Tablet	SCD	29082d8c-bbde-4620-924f-02dcf1764919	10
200031	carvedilol 6.25 MG Oral Tablet	SCD	29082d8c-bbde-4620-924f-02dcf1764919	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65841-616-01	65841061601	100 TABLET, FILM COATED in 1 BOTTLE (65841-616-01)	2007-09-05	0000-00-00	No	No	Current
65841-616-05	65841061605	500 TABLET, FILM COATED in 1 BOTTLE (65841-616-05)	2007-09-05	0000-00-00	No	No	Current
65841-616-17	65841061617	28 TABLET, FILM COATED in 1 BOTTLE (65841-616-17)	2007-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARVEDILOL TABLETS	Zydus Lifesciences Limited \| Zydus Pharmaceuticals Limited	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	10