Carvedilol Phosphate

Product NDC: 67046-1551
11-digit product format: 670461551
Labeler code: 67046
Product ID: 67046-1551_325da392-3ebb-37a2-e063-6394a90ad39d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol Phosphate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Coupler LLC
Application: ANDA090132
Marketing category: ANDA
Marketing start: 2025-04-09
Substance: CARVEDILOL PHOSPHATE
Active strength: 10 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
A090132-001	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25
A090132-002	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25
A090132-003	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25
A090132-004	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090132-001	AB
A090132-002	AB
A090132-003	AB
A090132-004	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2017-10-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2017-10-25	`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	A090132-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090132-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090132-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090132-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090132-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090132-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090132-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090132-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090132-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090132-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090132-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090132-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090132-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carvedilol Phosphate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARVEDILOL PHOSPHATE	10 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860510	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
325dae60-01ce-a120-e063-6294a90a2ef2	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
67046-1551-3	Carvedilol Phosphate	30 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1551	CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [COUPLER LLC]	1	Current NDC, 1 package rows	20250410_325dae60-01ce-a120-e063-6294a90a2ef2.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Bryant Ranch Prepack	3697789e-ed17-4433-af94-e8ea19d8e04d	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Bryant Ranch Prepack	ce9623f8-6cea-45e0-a15c-2dd78690f2a7	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	NorthStar RxLLC	63065e30-4a50-42b0-9622-a393923c1e98	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Golden State Medical Supply, Inc.	669ec7f8-f27d-4048-a784-00ca903cc658	2026-01-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Sun Pharmaceutical Industries, Inc.	a9314bc0-fd5d-477b-bef5-3bee532774c0	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Bryant Ranch Prepack	c462ce0b-486d-4599-ba60-b836781779d3	2025-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Bryant Ranch Prepack	cea10014-72b0-4190-a391-733c8912efe0	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Coupler LLC	325dae60-01ce-a120-e063-6294a90a2ef2	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090132 application number: ANDA090132 ndc (product): 67046-1551

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	325dae60-01ce-a120-e063-6294a90a2ef2	1
860510	24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule	SCD	325dae60-01ce-a120-e063-6294a90a2ef2	1
860510	carvedilol phosphate 10 MG 24 HR Extended Release Oral Capsule	SY	325dae60-01ce-a120-e063-6294a90a2ef2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
67046-1551-3	67046155103	30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1551-3)	2025-04-09	No	No	Current