Carvedilol

Product NDC: 68382-092
11-digit product format: 683820092
Labeler code: 68382
Product ID: 68382-092_a7e5dd69-ac10-4f36-a366-4ddc1426aef1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
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 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A077614-001	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077614-002	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077614-003	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077614-004	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077614-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077614-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077614-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077614-004	AB	1	`c2088c7a36db…`
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…`

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
dc6a2d33-aa04-4a04-9cde-901b744d24ca	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
c09e7fc3-90f5-4f9d-96f4-e1a857de4102	Product name	1	20230718
36aa7500-f1f6-4316-9cf2-688d1cdea23a	Product name	1	20190402
e148a93c-bfff-2735-e6c0-0739297b4596	Product name	3	20180705
15592b85-0e03-4d08-b78d-bef98f30a3f5	Product name	1	20180529
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
68382-092-01	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100	16
68382-092-05	Carvedilol	500 in 1 BOTTLE	TABLET, FILM COATED	500	16
68382-092-17	Carvedilol	28 in 1 BOTTLE	TABLET, FILM COATED	28	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-092-01	EA - Each	68382-092	65cec951-d2e7-49b5-86c3-eb3a06650caf	1	2012-07-24
68382-092-05	EA - Each	68382-092	b62f293d-1ebe-47e7-9c4c-60ecc3723e49	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOLEVULINIC ACID HYDROCHLORIDE	INACTIVE INGREDIENT	V35KBM8JGR	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOMETRADINE	INACTIVE INGREDIENT	PPM8SX5Q3V	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPENTAMIDE SULFATE	INACTIVE INGREDIENT	20P9NI883O	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPHYLLINE	INACTIVE INGREDIENT	27Y3KJK423	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPROMAZINE	INACTIVE INGREDIENT	S9SDD93U5U	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPROPAZINE FUMARATE	INACTIVE INGREDIENT	9KWA4W69IW	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMINOPTERIN SODIUM	INACTIVE INGREDIENT	FZU1QI13O9	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMMI VISNAGA FRUIT	INACTIVE INGREDIENT	3UN285QN0C	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
AMOPROXAN	INACTIVE INGREDIENT	27RL57FCYM	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	7
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]	2
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMINOLEVULINIC ACID HYDROCHLORIDE	INACTIVE INGREDIENT	V35KBM8JGR	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMINOMETRADINE	INACTIVE INGREDIENT	PPM8SX5Q3V	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMINOPENTAMIDE SULFATE	INACTIVE INGREDIENT	20P9NI883O	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMINOPHYLLINE	INACTIVE INGREDIENT	27Y3KJK423	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMINOPROMAZINE	INACTIVE INGREDIENT	S9SDD93U5U	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMINOPROPAZINE FUMARATE	INACTIVE INGREDIENT	9KWA4W69IW	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMINOPTERIN SODIUM	INACTIVE INGREDIENT	FZU1QI13O9	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMMI VISNAGA FRUIT	INACTIVE INGREDIENT	3UN285QN0C	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
AMOPROXAN	INACTIVE INGREDIENT	27RL57FCYM	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-092	CARVEDILOL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	15	Current NDC, Legacy NDC, 3 package rows	20231216_dc6a2d33-aa04-4a04-9cde-901b744d24ca.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
686924	carvedilol 3.125 MG Oral Tablet	PSN	32098c09-7580-4975-a3e1-31b619c04c69	19
686924	carvedilol 3.125 MG Oral Tablet	PSN	444ee05c-571a-4ea6-8763-af05d252df56	19
686924	carvedilol 3.125 MG Oral Tablet	SCD	32098c09-7580-4975-a3e1-31b619c04c69	19
686924	carvedilol 3.125 MG Oral Tablet	SCD	444ee05c-571a-4ea6-8763-af05d252df56	19
200032	carvedilol 12.5 MG Oral Tablet	PSN	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200033	carvedilol 25 MG Oral Tablet	PSN	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
686924	carvedilol 3.125 MG Oral Tablet	PSN	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
686924	carvedilol 3.125 MG Oral Tablet	PSN	b23021d4-c00a-e0ef-eb93-1dc824ae56ca	16
200031	carvedilol 6.25 MG Oral Tablet	PSN	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200032	carvedilol 12.5 MG Oral Tablet	SCD	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
200033	carvedilol 25 MG Oral Tablet	SCD	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
686924	carvedilol 3.125 MG Oral Tablet	SCD	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
686924	carvedilol 3.125 MG Oral Tablet	SCD	b23021d4-c00a-e0ef-eb93-1dc824ae56ca	16
200031	carvedilol 6.25 MG Oral Tablet	SCD	dc6a2d33-aa04-4a04-9cde-901b744d24ca	16
686924	carvedilol 3.125 MG Oral Tablet	PSN	3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231	9
686924	carvedilol 3.125 MG Oral Tablet	SCD	3eb4fd8e-1027-4d24-8f2f-12e9dcfe6231	9
686924	carvedilol 3.125 MG Oral Tablet	PSN	3b56e0d0-82d7-4512-849f-2b72d7bae36e	5
686924	carvedilol 3.125 MG Oral Tablet	PSN	0bfea06d-7abe-407a-80a4-d15d373569f7	5
686924	carvedilol 3.125 MG Oral Tablet	PSN	add1ee3d-fca4-4301-b871-7dda6eda7bb7	5
686924	carvedilol 3.125 MG Oral Tablet	PSN	010290af-81f4-0037-e063-6394a90a4638	5
686924	carvedilol 3.125 MG Oral Tablet	SCD	add1ee3d-fca4-4301-b871-7dda6eda7bb7	5
686924	carvedilol 3.125 MG Oral Tablet	SCD	010290af-81f4-0037-e063-6394a90a4638	5
686924	carvedilol 3.125 MG Oral Tablet	SCD	3b56e0d0-82d7-4512-849f-2b72d7bae36e	5
686924	carvedilol 3.125 MG Oral Tablet	SCD	0bfea06d-7abe-407a-80a4-d15d373569f7	5
686924	carvedilol 3.125 MG Oral Tablet	PSN	49afdf89-0bed-71da-e054-00144ff88e88	4
686924	carvedilol 3.125 MG Oral Tablet	PSN	f2a0407c-2e05-60eb-e053-2a95a90abc99	4
686924	carvedilol 3.125 MG Oral Tablet	SCD	49afdf89-0bed-71da-e054-00144ff88e88	4
686924	carvedilol 3.125 MG Oral Tablet	SCD	f2a0407c-2e05-60eb-e053-2a95a90abc99	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-092-01	68382009201	100 TABLET, FILM COATED in 1 BOTTLE (68382-092-01)	2007-09-05	0000-00-00	No	No	Current
68382-092-05	68382009205	500 TABLET, FILM COATED in 1 BOTTLE (68382-092-05)	2007-09-05	0000-00-00	No	No	Current
68382-092-17	68382009217	28 TABLET, FILM COATED in 1 BOTTLE (68382-092-17)	2007-09-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carvedilol	REMEDYREPACK INC.	2026-07-06	HUMAN PRESCRIPTION DRUG LABEL	20
Carvedilol	QPharma Inc \| Zydus Pharmaceuticals USA Inc. \| Northwind Health Company, LLC	2026-05-11	HUMAN PRESCRIPTION DRUG LABEL	5
Carvedilol	Bryant Ranch Prepack	2026-04-02	HUMAN PRESCRIPTION DRUG LABEL	16
Carvedilol	Preferred Pharmaceuticals Inc.	2026-03-20	HUMAN PRESCRIPTION DRUG LABEL	5
Carvedilol	A-S Medication Solutions	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	9
Carvedilol	A-S Medication Solutions	2026-02-13	HUMAN PRESCRIPTION DRUG LABEL	5
Carvedilol	PD-Rx Pharmaceuticals, Inc.	2026-01-20	HUMAN PRESCRIPTION DRUG LABEL	19
Carvedilol	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited \| Zydus Pharmaceuticals Limited	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	16
Carvedilol	Northwind Health Company, LLC	2025-12-26	HUMAN PRESCRIPTION DRUG LABEL	4
Carvedilol	Proficient Rx LP	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	5
Carvedilol	NuCare Pharmaceuticals, Inc.	2024-01-12	HUMAN PRESCRIPTION DRUG LABEL	4
Carvedilol	REMEDYREPACK INC.	2022-06-21	HUMAN PRESCRIPTION DRUG LABEL	6