Carvedilol

Product NDC: 55154-5677
11-digit product format: 551545677
Labeler code: 55154
Product ID: 55154-5677_047065cc-d470-4b94-b65f-4ce62eb49f12
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA077316
Marketing category: ANDA
Marketing start: 2011-02-18
Marketing end: 0000-00-00
Substance: CARVEDILOL
Active strength: 3 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	55154-5677		D	Discontinued by firm		2026-10-16
excluded package	package	55154-5677	55154-5677-0	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-5677-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55154-5677-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55154-5677-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55154-5677-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55154-5677-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55154-5677-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55154-5677-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55154-5677-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55154-5677-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55154-5677-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55154-5677-0	`367a005e9d99…`	`383a685ebd0f…`

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	Approval date
A077316-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05
A077316-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05
A077316-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05
A077316-004	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05

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	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 137 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A077316-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077316-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077316-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077316-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077316-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077316-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077316-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077316-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077316-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077316-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077316-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077316-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077316-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077316-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077316-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077316-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077316-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077316-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077316-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077316-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077316-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077316-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077316-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077316-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077316-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077316-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077316-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077316-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077316-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077316-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077316-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077316-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077316-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077316-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077316-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077316-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077316-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077316-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077316-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077316-003	AB	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55154-5677-0	EA - Each	55154-5677	2d2c2d59-41f1-459c-bc4c-77a574f6f430	1	2020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]	15

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-5677-0	55154567700	10 BLISTER PACK in 1 BAG (55154-5677-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2011-02-18	0000-00-00	No	No	Current