Coreg CR

Product NDC: 80725-388
11-digit product format: 807250388
Labeler code: 80725
Product ID: 80725-388_d756f678-86ff-4187-9cc1-68dd3a383af8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol Phosphate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Waylis Therapeutics LLC
Application: NDA022012
Marketing category: NDA
Marketing start: 2022-11-07
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: 2026-12-31
Current FDA listing: Yes

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	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 · 168 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
2026-08-18 06:07:40	2026-07	N022012-001	COREG CR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-002	COREG CR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-003	COREG CR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-004	COREG CR	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	2006-10-20	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 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	N022012-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-004	AB	1	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 624 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022012-001	8101209	2025-09-11	Drug product	2012-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-001	8101209*PED	2026-03-11	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-002	8101209	2025-09-11	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-002	8101209*PED	2026-03-11	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-003	8101209	2025-09-11	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-003	8101209*PED	2026-03-11	Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-004	8101209	2025-09-11	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022012-004	8101209*PED	2026-03-11	Pediatric extension		`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Coreg CR
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARVEDILOL PHOSPHATE	80 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EQT531S367	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860510	Internal RxNorm lookup
860512	Internal RxNorm lookup
860516	Internal RxNorm lookup
860518	Internal RxNorm lookup
860522	Internal RxNorm lookup
860524	Internal RxNorm lookup
860532	Internal RxNorm lookup
860534	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
d3625d78-6eb6-41fe-8f6f-664965c104c4	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	Strength	SPL version
80725-388-13	Coreg CR	30 in 1 BOTTLE, PLASTIC	CAPSULE, EXTENDED RELEASE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80725-388-13	EA - Each	80725-388	1042e474-59c8-4932-8721-71308f3e2fda	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80725-388	COREG CR (CARVEDILOL PHOSPHATE) CAPSULE, EXTENDED RELEASE [WAYLIS THERAPEUTICS LLC]	3	Current NDC, 1 package rows	20250427_d3625d78-6eb6-41fe-8f6f-664965c104c4.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
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 ndc (product): 80725-388

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860510	carvedilol phosphate 10 MG 24HR Extended Release Oral Capsule	PSN	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860516	carvedilol phosphate 20 MG 24HR Extended Release Oral Capsule	PSN	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860522	carvedilol phosphate 40 MG 24HR Extended Release Oral Capsule	PSN	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860532	carvedilol phosphate 80 MG 24HR Extended Release Oral Capsule	PSN	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860512	COREG CR 10 MG 24HR Extended Release Oral Capsule	PSN	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860518	COREG CR 20 MG 24HR Extended Release Oral Capsule	PSN	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860524	Coreg CR 40 MG 24HR Extended Release Oral Capsule	PSN	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860534	COREG CR 80 MG 24HR Extended Release Oral Capsule	PSN	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860512	24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule [Coreg]	SBD	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860518	24 HR carvedilol phosphate 20 MG Extended Release Oral Capsule [Coreg]	SBD	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860524	24 HR carvedilol phosphate 40 MG Extended Release Oral Capsule [Coreg]	SBD	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860534	24 HR carvedilol phosphate 80 MG Extended Release Oral Capsule [Coreg]	SBD	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860510	24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule	SCD	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860516	24 HR carvedilol phosphate 20 MG Extended Release Oral Capsule	SCD	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860522	24 HR carvedilol phosphate 40 MG Extended Release Oral Capsule	SCD	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860532	24 HR carvedilol phosphate 80 MG Extended Release Oral Capsule	SCD	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860512	24 HR Coreg 10 MG Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860518	24 HR Coreg 20 MG Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860524	24 HR Coreg 40 MG Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860534	24 HR Coreg 80 MG Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860510	carvedilol phosphate 10 MG 24 HR Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860516	carvedilol phosphate 20 MG 24 HR Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860522	carvedilol phosphate 40 MG 24 HR Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860532	carvedilol phosphate 80 MG 24 HR Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860512	Coreg CR 10 MG 24 HR Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860518	Coreg CR 20 MG 24 HR Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860524	Coreg CR 40 MG 24 HR Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3
860534	Coreg CR 80 MG 24 HR Extended Release Oral Capsule	SY	d3625d78-6eb6-41fe-8f6f-664965c104c4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80725-388-13	80725038813	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-388-13)	2022-11-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Coreg CR	Waylis Therapeutics LLC \| Recipharm Pessac S.A.S. \| Bora Pharmaceuticals \| Future Pak LLC	2025-04-25	HUMAN PRESCRIPTION DRUG LABEL	3