COREG

Product NDC: 0007-3388
11-digit product format: 000073388
Labeler code: 0007
Product ID: 0007-3388_a25fd7cf-8270-4fc1-8e72-7b10ce17d088
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carvedilol phosphate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: GlaxoSmithKline LLC
Application: NDA022012
Marketing category: NDA
Marketing start: 2019-11-01
Marketing end: 0000-00-00
Substance: CARVEDILOL PHOSPHATE
Active strength: 80 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: 2022-12-31
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	0007-3388		D	Discontinued by firm		2026-08-10
excluded package	package	0007-3388	0007-3388-13	D	Discontinued by firm		2026-08-10

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 · 24 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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`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	0007-3388-13	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0007-3388-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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	RLD / RS	Approval date
N022012-001	COREG CR	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20
N022012-002	COREG CR	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20
N022012-003	COREG CR	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20
N022012-004	COREG CR	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022012-001	AB
N022012-002	AB
N022012-003	AB
N022012-004	AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N022012-001	8101209	2025-09-11	Drug product	2012-02-21
N022012-001	8101209*PED	2026-03-11	Pediatric extension
N022012-002	8101209	2025-09-11	Drug product
N022012-002	8101209*PED	2026-03-11	Pediatric extension
N022012-003	8101209	2025-09-11	Drug product
N022012-003	8101209*PED	2026-03-11	Pediatric extension
N022012-004	8101209	2025-09-11	Drug product
N022012-004	8101209*PED	2026-03-11	Pediatric extension

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL		RLD	2006-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022012-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022012-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-004	AB	1	`6a471c1ec25d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022012-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022012-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022012-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022012-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022012-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022012-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022012-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022012-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022012-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022012-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022012-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022012-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022012-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022012-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022012-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022012-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022012-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022012-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022012-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022012-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022012-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022012-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022012-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022012-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022012-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022012-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022012-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022012-004	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 616 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022012-001	8101209	2025-09-11	Drug product	2012-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-001	8101209*PED	2026-03-11	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-002	8101209	2025-09-11	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-002	8101209*PED	2026-03-11	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-003	8101209	2025-09-11	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-003	8101209*PED	2026-03-11	Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-004	8101209	2025-09-11	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022012-004	8101209*PED	2026-03-11	Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-001	8101209	2025-09-11	Drug product	2012-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-001	8101209*PED	2026-03-11	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-002	8101209	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-002	8101209*PED	2026-03-11	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-003	8101209	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-003	8101209*PED	2026-03-11	Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-004	8101209	2025-09-11	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022012-004	8101209*PED	2026-03-11	Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022012-001	8101209	2025-09-11	Drug product	2012-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-001	8101209*PED	2026-03-11	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-002	8101209	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-002	8101209*PED	2026-03-11	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-003	8101209	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-003	8101209*PED	2026-03-11	Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-004	8101209	2025-09-11	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022012-004	8101209*PED	2026-03-11	Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-001	8101209	2025-09-11	Drug product	2012-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-001	8101209*PED	2026-03-11	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-002	8101209	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-002	8101209*PED	2026-03-11	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-003	8101209	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-003	8101209*PED	2026-03-11	Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-004	8101209	2025-09-11	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022012-004	8101209*PED	2026-03-11	Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-001	8101209	2025-09-11	Drug product	2012-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-001	8101209*PED	2026-03-11	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-002	8101209	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-002	8101209*PED	2026-03-11	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-003	8101209	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-003	8101209*PED	2026-03-11	Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-004	8101209	2025-09-11	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022012-004	8101209*PED	2026-03-11	Pediatric extension		`b8a1b40f171c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0007-3388-13	2023-02-12	C162847	48780-1	f386c649-b0ed-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use COREG CR safely and effectively. See full prescribing information for COREG CR. COREG CR (carvedilol phosphate) extended-release capsules for oral use Initial U.S. Approval: 1995
0007-3388-13	2023-01-30	C162847	48780-1	f386c649-b0ed-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use COREG CR safely and effectively. See full prescribing information for COREG CR. COREG CR (carvedilol phosphate) extended-release capsules for oral use Initial U.S. Approval: 1995

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL PHOSPHATE	ACTIVE INGREDIENT	EQT531S367	COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	18
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	18
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	18
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	18
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	18
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	18
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [GLAXOSMITHKLINE LLC]	18

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
Coreg CR	CARVEDILOL PHOSPHATE	Waylis Therapeutics LLC	d3625d78-6eb6-41fe-8f6f-664965c104c4	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022012 application number: NDA022012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EQT531S367	CARVEDILOL PHOSPHATE	610309-89-2	CARVEDILOL PHOSPHATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0007-3388-13	00007338813	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0007-3388-13)	2019-11-01	0000-00-00	No	No	Current