Carvedilol

Product NDC: 68788-9789
11-digit product format: 687889789
Labeler code: 68788
Product ID: 68788-9789_8cbf4bb1-72f2-4e70-9a43-ba62d8fb3317
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals,Inc.
Application: ANDA077614
Marketing category: ANDA
Marketing start: 2012-06-04
Substance: CARVEDILOL
Active strength: 6.25 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: 2026-12-31
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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARVEDILOL	6.25 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200031	Internal RxNorm lookup
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
81bc612d-5674-45b9-a1f5-2cb4fa625747	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
68788-9789-1	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100	14
68788-9789-3	Carvedilol	30 in 1 BOTTLE	TABLET, FILM COATED	30	14
68788-9789-6	Carvedilol	60 in 1 BOTTLE	TABLET, FILM COATED	60	14
68788-9789-9	Carvedilol	90 in 1 BOTTLE	TABLET, FILM COATED	90	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMINOLEVULINIC ACID HYDROCHLORIDE	INACTIVE INGREDIENT	V35KBM8JGR	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMINOMETRADINE	INACTIVE INGREDIENT	PPM8SX5Q3V	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMINOPENTAMIDE SULFATE	INACTIVE INGREDIENT	20P9NI883O	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMINOPHYLLINE	INACTIVE INGREDIENT	27Y3KJK423	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMINOPROMAZINE	INACTIVE INGREDIENT	S9SDD93U5U	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMINOPROPAZINE FUMARATE	INACTIVE INGREDIENT	9KWA4W69IW	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMINOPTERIN SODIUM	INACTIVE INGREDIENT	FZU1QI13O9	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMMI VISNAGA FRUIT	INACTIVE INGREDIENT	3UN285QN0C	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
AMOPROXAN	INACTIVE INGREDIENT	27RL57FCYM	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-9789	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS,INC.]	14	Current NDC, Legacy NDC, 4 package rows	20250216_81bc612d-5674-45b9-a1f5-2cb4fa625747.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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	d7d6bfff-fbb6-4a1f-aa13-babbb9a1e878	2026-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	St. Mary's Medical Park Pharmacy	8a82149f-aade-2a9b-e053-2995a90a9daf	2026-08-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	c5b907f8-84a0-5fb2-e7ec-4c82246195f5	2026-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Coupler LLC	58280d18-5960-1730-e063-6394a90a4f64	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	ab8aa773-0ed1-4d59-a1bb-f46cf882644f	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	0e98593a-8424-48c8-acc0-671f4b566aee	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	32098c09-7580-4975-a3e1-31b619c04c69	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	196536eb-8b94-45da-a2f3-f554d6bf88e9	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	39cf31cc-8f3d-4919-a93a-f997ad6850dc	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	REMEDYREPACK INC.	6eec3476-f6db-45bd-bb91-4b2d5fbd0f5f	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	St. Mary's Medical Park Pharmacy	ed11cd4e-d7c9-8446-e053-2995a90afd6e	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Coupler LLC	52bd1d20-08ba-1e5e-e063-6294a90ae8a9	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Coupler LLC	51b403dc-fc9f-0cad-e063-6394a90af081	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	QPharma Inc	010290af-81f4-0037-e063-6394a90a4638	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	b23021d4-c00a-e0ef-eb93-1dc824ae56ca	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals, Inc.	5c34847d-68f9-4967-81c8-a2297a6acb7f	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Preferred Pharmaceuticals Inc.	3b56e0d0-82d7-4512-849f-2b72d7bae36e	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	BluePoint Laboratories	e68c9b18-e7fd-45f7-a8f5-1d815e32680b	2026-03-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077614 application number: ANDA077614
Carvedilol	CARVEDILOL	Direct_Rx	4c48ba6b-4e1e-5116-e063-6394a90aa793	2026-03-05	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
200033	carvedilol 25 MG Oral Tablet	PSN	81bc612d-5674-45b9-a1f5-2cb4fa625747	14
200031	carvedilol 6.25 MG Oral Tablet	PSN	81bc612d-5674-45b9-a1f5-2cb4fa625747	14
200033	carvedilol 25 MG Oral Tablet	SCD	81bc612d-5674-45b9-a1f5-2cb4fa625747	14
200031	carvedilol 6.25 MG Oral Tablet	SCD	81bc612d-5674-45b9-a1f5-2cb4fa625747	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-9789-1	68788978901	100 TABLET, FILM COATED in 1 BOTTLE (68788-9789-1)	2012-06-04	0000-00-00	No	No	Current
68788-9789-3	68788978903	30 TABLET, FILM COATED in 1 BOTTLE (68788-9789-3)	2012-06-04	0000-00-00	No	No	Current
68788-9789-6	68788978906	60 TABLET, FILM COATED in 1 BOTTLE (68788-9789-6)	2012-06-04	0000-00-00	No	No	Current
68788-9789-9	68788978909	90 TABLET, FILM COATED in 1 BOTTLE (68788-9789-9)	2012-06-04	0000-00-00	No	No	Current