Carvedilol

Product NDC: 68788-0253
11-digit product format: 687880253
Labeler code: 68788
Product ID: 68788-0253_ac3d3aa4-c029-468f-a49c-e6a93fc92111
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc
Application: ANDA076649
Marketing category: ANDA
Marketing start: 2007-09-05
Marketing end: 0000-00-00
Substance: CARVEDILOL
Active strength: 6 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: E
Listing certified through: 2017-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68788-0253		I	Inactivated by FDA	2026-08-17
excluded package	package	68788-0253	68788-0253-0	I	Inactivated by FDA	2026-08-17
excluded package	package	68788-0253	68788-0253-3	I	Inactivated by FDA	2026-08-17
excluded package	package	68788-0253	68788-0253-6	I	Inactivated by FDA	2026-08-17
excluded package	package	68788-0253	68788-0253-8	I	Inactivated by FDA	2026-08-17
excluded package	package	68788-0253	68788-0253-9	I	Inactivated by FDA	2026-08-17

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 3 · 132 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	68788-0253-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-0253-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-0253-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-0253-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68788-0253-6	`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	68788-0253-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-0253-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-0253-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-0253-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68788-0253-6	`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	68788-0253-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-0253-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-0253-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-0253-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68788-0253-6	`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	68788-0253-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-0253-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-0253-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-0253-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68788-0253-6	`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	68788-0253-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-0253-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-0253-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-0253-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68788-0253-6	`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	68788-0253-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-0253-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-0253-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-0253-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68788-0253-6	`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	68788-0253-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-0253-8	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-0253-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-0253-0	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68788-0253-6	`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	68788-0253-9	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-0253-8	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-0253-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-0253-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68788-0253-6	`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	68788-0253-9	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-0253-8	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-0253-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-0253-0	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68788-0253-6	`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	68788-0253-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-0253-8	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-0253-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-0253-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68788-0253-6	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A076649-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A076649-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A076649-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A076649-004	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
A076649-001	AB
A076649-002	AB
A076649-003	AB
A076649-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076649-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076649-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076649-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076649-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A076649-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076649-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076649-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076649-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076649-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076649-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076649-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076649-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076649-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076649-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076649-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076649-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076649-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076649-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076649-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076649-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076649-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076649-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076649-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076649-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076649-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076649-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076649-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076649-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076649-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076649-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076649-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076649-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076649-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076649-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076649-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076649-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076649-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076649-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076649-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076649-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076649-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076649-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076649-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076649-004	AB	1	`d8e5a09893c0…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
68788-0253-0	These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995
68788-0253-3	These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995
68788-0253-6	These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995
68788-0253-8	These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995
68788-0253-9	These highlights do not include all the information needed to use carvedilol tablets safely and effectively. See full prescribing information for carvedilol tablets. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-0253-0	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
68788-0253-3	Carvedilol	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
68788-0253-6	Carvedilol	60 in 1 BOTTLE	TABLET, FILM COATED	60	13
68788-0253-8	Carvedilol	120 in 1 BOTTLE	TABLET, FILM COATED	120	13
68788-0253-9	Carvedilol	90 in 1 BOTTLE	TABLET, FILM COATED	90	13

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]	13
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-0253	CARVEDILOL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	13	Legacy NDC, 5 package rows	20130506_9bab0a6b-8ed4-46e4-8326-2f9e3c87559b.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Dr. Reddy's Laboratories Limited	1e453c21-a8a8-dc54-5591-74c972d41727	2018-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076649 application number: ANDA076649

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
200031	carvedilol 6.25 MG Oral Tablet	PSN	9bab0a6b-8ed4-46e4-8326-2f9e3c87559b	13
200031	carvedilol 6.25 MG Oral Tablet	SCD	9bab0a6b-8ed4-46e4-8326-2f9e3c87559b	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68788-0253-0	68788025300	100 in 1 BOTTLE	Historical
68788-0253-3	68788025303	30 in 1 BOTTLE	Historical
68788-0253-6	68788025306	60 in 1 BOTTLE	Historical
68788-0253-8	68788025308	120 in 1 BOTTLE	Historical
68788-0253-9	68788025309	90 in 1 BOTTLE	Historical