Carvedilol

Product NDC: 0093-0051
11-digit product format: 000930051
Labeler code: 0093
Product ID: 0093-0051_3d07d8c6-ffea-41c3-a50c-4e3d723de14f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carvedilol
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA076373
Marketing category: ANDA
Marketing start: 2007-09-06
Substance: CARVEDILOL
Active strength: 3.125 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 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	Approval date
A076373-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A076373-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A076373-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A076373-004	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
A076373-001	AB
A076373-002	AB
A076373-003	AB
A076373-004	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A076373-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A076373-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076373-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	CARVEDILOL	A-S Medication Solutions	fe2d5c95-c101-4b01-89fd-0fd6d25ad80b	2026-04-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	QPharma, Inc.	ffbedcce-0d64-4aed-9e65-09448d71ca91	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	52785a22-ddca-4f5b-8579-5974df2a9a4e	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	NCS HealthCare of KY, LLC dba Vangard Labs	2fb46fe1-9b7b-4718-9327-2471af22f0b7	2025-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	da2696ba-f4be-4626-9abe-fe33f36361b1	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Proficient Rx LP	c0202d0f-2ffc-45f2-a98d-5f05ac1eaa85	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373
Carvedilol	CARVEDILOL	Teva Pharmaceuticals USA, Inc.	68c275e8-992a-4520-8065-ab6d615d89cc	2024-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076373 application number: ANDA076373 ndc (product): 0093-0051

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARVEDILOL	3.125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0K47UL67F2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200031	Internal RxNorm lookup
200032	Internal RxNorm lookup
200033	Internal RxNorm lookup
686924	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
68c275e8-992a-4520-8065-ab6d615d89cc	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
0093-0051-01	Carvedilol	100 in 1 BOTTLE	TABLET, FILM COATED	100		16
0093-0051-05	Carvedilol	500 in 1 BOTTLE	TABLET, FILM COATED	500		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0051-01	EA - Each	0093-0051	cc1a6b4d-5760-4fdf-b9e7-6c989ed688bd	1	2012-07-24
0093-0051-05	EA - Each	0093-0051	38941d48-17d6-4212-9d9b-b7dc553c994d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]	10
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0051	CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]	16	Current NDC, Legacy NDC, 2 package rows	20240426_68c275e8-992a-4520-8065-ab6d615d89cc.zip

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
200032	carvedilol 12.5 MG Oral Tablet	PSN	68c275e8-992a-4520-8065-ab6d615d89cc	16
200033	carvedilol 25 MG Oral Tablet	PSN	68c275e8-992a-4520-8065-ab6d615d89cc	16
686924	carvedilol 3.125 MG Oral Tablet	PSN	68c275e8-992a-4520-8065-ab6d615d89cc	16
200031	carvedilol 6.25 MG Oral Tablet	PSN	68c275e8-992a-4520-8065-ab6d615d89cc	16
200032	carvedilol 12.5 MG Oral Tablet	SCD	68c275e8-992a-4520-8065-ab6d615d89cc	16
200033	carvedilol 25 MG Oral Tablet	SCD	68c275e8-992a-4520-8065-ab6d615d89cc	16
686924	carvedilol 3.125 MG Oral Tablet	SCD	68c275e8-992a-4520-8065-ab6d615d89cc	16
200031	carvedilol 6.25 MG Oral Tablet	SCD	68c275e8-992a-4520-8065-ab6d615d89cc	16
200032	carvedilol 12.5 MG Oral Tablet	PSN	2fb46fe1-9b7b-4718-9327-2471af22f0b7	8
200033	carvedilol 25 MG Oral Tablet	PSN	2fb46fe1-9b7b-4718-9327-2471af22f0b7	8
686924	carvedilol 3.125 MG Oral Tablet	PSN	2fb46fe1-9b7b-4718-9327-2471af22f0b7	8
200031	carvedilol 6.25 MG Oral Tablet	PSN	2fb46fe1-9b7b-4718-9327-2471af22f0b7	8
200032	carvedilol 12.5 MG Oral Tablet	SCD	2fb46fe1-9b7b-4718-9327-2471af22f0b7	8
200033	carvedilol 25 MG Oral Tablet	SCD	2fb46fe1-9b7b-4718-9327-2471af22f0b7	8
686924	carvedilol 3.125 MG Oral Tablet	SCD	2fb46fe1-9b7b-4718-9327-2471af22f0b7	8
200031	carvedilol 6.25 MG Oral Tablet	SCD	2fb46fe1-9b7b-4718-9327-2471af22f0b7	8
686924	carvedilol 3.125 MG Oral Tablet	PSN	fe2d5c95-c101-4b01-89fd-0fd6d25ad80b	6
686924	carvedilol 3.125 MG Oral Tablet	PSN	ffbedcce-0d64-4aed-9e65-09448d71ca91	6
686924	carvedilol 3.125 MG Oral Tablet	SCD	fe2d5c95-c101-4b01-89fd-0fd6d25ad80b	6
686924	carvedilol 3.125 MG Oral Tablet	SCD	ffbedcce-0d64-4aed-9e65-09448d71ca91	6
686924	carvedilol 3.125 MG Oral Tablet	PSN	b4647b22-9a70-4259-a8f6-fac0ce1ac5c5	1
686924	carvedilol 3.125 MG Oral Tablet	PSN	c0202d0f-2ffc-45f2-a98d-5f05ac1eaa85	1
686924	carvedilol 3.125 MG Oral Tablet	SCD	b4647b22-9a70-4259-a8f6-fac0ce1ac5c5	1
686924	carvedilol 3.125 MG Oral Tablet	SCD	c0202d0f-2ffc-45f2-a98d-5f05ac1eaa85	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0051-01	00093005101	100 TABLET, FILM COATED in 1 BOTTLE (0093-0051-01)	2007-09-06	0000-00-00	No	No	Current
0093-0051-05	00093005105	500 TABLET, FILM COATED in 1 BOTTLE (0093-0051-05)	2008-12-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carvedilol	A-S Medication Solutions	2026-04-26	HUMAN PRESCRIPTION DRUG LABEL	6
Carvedilol	QPharma, Inc. \| Teva Pharmaceuticals USA, Inc. \| Northwind Health Company, LLC	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	6
Carvedilol	NCS HealthCare of KY, LLC dba Vangard Labs	2025-06-11	HUMAN PRESCRIPTION DRUG LABEL	8
Carvedilol	Proficient Rx LP	2025-02-01	HUMAN PRESCRIPTION DRUG LABEL	1
Carvedilol	RPK Pharmaceuticals, Inc.	2024-12-19	HUMAN PRESCRIPTION DRUG LABEL	2
Carvedilol	Teva Pharmaceuticals USA, Inc.	2024-03-25	HUMAN PRESCRIPTION DRUG LABEL	16
Carvedilol	MedVantx, Inc. \| Teva Pharmaceuticals USA Inc \| Blenheim Pharmacal, Inc.	2011-09-13	HUMAN PRESCRIPTION DRUG LABEL	1