Carvedilol Phosphate

Product NDC: 42291-481
11-digit product format: 422910481
Labeler code: 42291
Product ID: 42291-481_4a7c3ea5-24e9-8ace-e063-6294a90a879d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol Phosphate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: AvKARE
Application: ANDA204717
Marketing category: ANDA
Marketing start: 2024-06-27
Substance: CARVEDILOL PHOSPHATE
Active strength: 40 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: 2027-12-31
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	Approval date
A204717-001	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07
A204717-002	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07
A204717-003	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07
A204717-004	CARVEDILOL PHOSPHATE	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204717-001	AB
A204717-002	AB
A204717-003	AB
A204717-004	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	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204717-001	CARVEDILOL PHOSPHATE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204717-002	CARVEDILOL PHOSPHATE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204717-003	CARVEDILOL PHOSPHATE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204717-004	CARVEDILOL PHOSPHATE	80MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-05-07	`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	A204717-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204717-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204717-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204717-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204717-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204717-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204717-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204717-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204717-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204717-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204717-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204717-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204717-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204717-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204717-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204717-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204717-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204717-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204717-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204717-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204717-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204717-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204717-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204717-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204717-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204717-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204717-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204717-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204717-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204717-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204717-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204717-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204717-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204717-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204717-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204717-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204717-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204717-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204717-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204717-004	AB	1	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carvedilol Phosphate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARVEDILOL PHOSPHATE	40 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860510	Internal RxNorm lookup
860516	Internal RxNorm lookup
860522	Internal RxNorm lookup
860532	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
1be1b5d2-eb2c-1d02-e063-6294a90adbba	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
42291-481-30	Carvedilol Phosphate	30 in 1 BOTTLE	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
42291-481-30	EA - Each	42291-481	3ea3481e-8378-4d72-8f8b-a4de4a5f819e	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-481	CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [AVKARE]	1	Current NDC, 1 package rows	20240629_1be1b5d2-eb2c-1d02-e063-6294a90adbba.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	AvKARE	1be1b5d2-eb2c-1d02-e063-6294a90adbba	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204717 application number: ANDA204717 ndc (product): 42291-481
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Amneal Pharmaceuticals NY LLC	dbec7c4b-3db7-4c9d-b5da-e72050ee5743	2025-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204717 application number: ANDA204717
Carvedilol Phosphate	CARVEDILOL PHOSPHATE	Amneal Pharmaceuticals of New York LLC	fa6b4014-e9d7-4074-95fc-4b48d91da83b	2025-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204717 application number: ANDA204717

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	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860516	carvedilol phosphate 20 MG 24HR Extended Release Oral Capsule	PSN	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860522	carvedilol phosphate 40 MG 24HR Extended Release Oral Capsule	PSN	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860532	carvedilol phosphate 80 MG 24HR Extended Release Oral Capsule	PSN	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860510	24 HR carvedilol phosphate 10 MG Extended Release Oral Capsule	SCD	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860516	24 HR carvedilol phosphate 20 MG Extended Release Oral Capsule	SCD	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860522	24 HR carvedilol phosphate 40 MG Extended Release Oral Capsule	SCD	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860532	24 HR carvedilol phosphate 80 MG Extended Release Oral Capsule	SCD	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860510	carvedilol phosphate 10 MG 24 HR Extended Release Oral Capsule	SY	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860516	carvedilol phosphate 20 MG 24 HR Extended Release Oral Capsule	SY	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860522	carvedilol phosphate 40 MG 24 HR Extended Release Oral Capsule	SY	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3
860532	carvedilol phosphate 80 MG 24 HR Extended Release Oral Capsule	SY	1be1b5d2-eb2c-1d02-e063-6294a90adbba	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
42291-481-30	42291048130	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-481-30)	2024-06-27	No	No	Current