Carvedilol

Product NDC: 82804-138
Requested package NDC: 82804-138-60
11-digit product format: 828040138
Labeler code: 82804
Product ID: 82804-138_baaecdf7-b67a-47f3-b42a-caf413bb9f4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA076373
Marketing category: ANDA
Marketing start: 2007-09-06
Substance: CARVEDILOL
Active strength: 25 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
A076373-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A076373-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A076373-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A076373-004	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
A076373-001	AB
A076373-002	AB
A076373-003	AB
A076373-004	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	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076373-004	CARVEDILOL	25MG	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	A076373-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076373-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076373-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076373-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076373-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076373-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076373-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076373-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076373-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076373-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076373-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076373-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076373-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076373-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076373-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076373-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076373-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076373-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076373-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076373-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076373-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076373-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076373-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076373-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076373-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076373-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076373-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076373-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076373-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076373-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076373-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076373-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076373-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076373-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076373-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076373-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076373-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076373-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076373-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076373-004	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	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200033	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
52785a22-ddca-4f5b-8579-5974df2a9a4e	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	Strength	SPL version
82804-138-60	Carvedilol	60 in 1 BOTTLE	TABLET, FILM COATED	60		2
82804-138-90	Carvedilol	90 in 1 BOTTLE	TABLET, FILM COATED	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-138-60	EA - Each	82804-138	2a234602-d49d-46d2-ac7d-cc9a3bf34b00	1	2026-02-05
82804-138-90	EA - Each	82804-138	099dc61f-11ae-4e27-ac17-1bbd6e842057	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-138	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1	Current NDC, 2 package rows	20240907_52785a22-ddca-4f5b-8579-5974df2a9a4e.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	A-S Medication Solutions	fe2d5c95-c101-4b01-89fd-0fd6d25ad80b	2026-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	QPharma, Inc.	ffbedcce-0d64-4aed-9e65-09448d71ca91	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	52785a22-ddca-4f5b-8579-5974df2a9a4e	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373 ndc (package): 82804-138-60 ndc (product): 82804-138 ndc11 (package): 82804013860
Carvedilol	CARVEDILOL	NCS HealthCare of KY, LLC dba Vangard Labs	2fb46fe1-9b7b-4718-9327-2471af22f0b7	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	da2696ba-f4be-4626-9abe-fe33f36361b1	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	c0202d0f-2ffc-45f2-a98d-5f05ac1eaa85	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Teva Pharmaceuticals USA, Inc.	68c275e8-992a-4520-8065-ab6d615d89cc	2024-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373

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
200033	carvedilol 25 MG Oral Tablet	PSN	52785a22-ddca-4f5b-8579-5974df2a9a4e	2
200033	carvedilol 25 MG Oral Tablet	SCD	52785a22-ddca-4f5b-8579-5974df2a9a4e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82804-138-60	82804013860	60 TABLET, FILM COATED in 1 BOTTLE (82804-138-60)	2025-12-04	No	No	Current