Carvedilol

Manufacturer: Northwind Pharmaceuticals
Effective date: 2014-05-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:14

Label at a glance#

ProductCarvedilol

Active ingredientCARVEDILOL

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-002-52

MFG: 0378-3633-01

Carvedilol 12.5 MG

30 Tablets

RX only

Lot#: NW07880001

Exp. Date: 1/2015

Each film-coated tablet contains: Carvedilol, USP...12.5mg

Dosage: See package insert

Store at 68 to 77 degrees F.

Protect from moisture.

Store in a tight, light-resistant container (See USP).

Keep out of the reach of children.

Mfg. by: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA Lot# 3044836

Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256

Carvedilol 51655-002

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-002-52	2026-01-13	C162847	48780-1	9d75b9d0-4fc3-f424-e053-dadaa90a57ce	b93697b3-c328-41b4-a012-13417bcc5169
51655-002-52	2020-01-31	C162847	48780-1	9d75b9d0-4fc3-f424-e053-dadaa90a57ce	b93697b3-c328-41b4-a012-13417bcc5169

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-002	CARVEDILOL TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20140516_b93697b3-c328-41b4-a012-13417bcc5169.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-3633-01	EA - Each	0378-3633	8fccb445-c462-455b-a6f2-21b81ca556ef	1	2012-07-24
0378-3633-02	EA - Each	0378-3633	5afcb926-e748-4fb5-bedc-d67f20d6c9d8	1	2013-02-13
0378-3633-05	EA - Each	0378-3633	90d8adb1-4464-4c1e-99a8-eca6706cedcf	1	2012-07-24
0378-3633-07	EA - Each	0378-3633	4fb5d782-f337-49c7-93b8-667caf12ccb2	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

Carvedilol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51655-002	51655-002-52
0378-3633

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CARVEDILOL	0K47UL67F2	ACTIB

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A077316-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	2007-09-05
A077316-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	2007-09-05
A077316-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	2007-09-05
A077316-004	CARVEDILOL	CARVEDILOL	25MG	TABLET / ORAL	2007-09-05

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 · 172 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
2026-09-14 22:38:34	2026-08	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL		2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL		2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077316-004	CARVEDILOL	25MG	TABLET / ORAL		2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077316-001	CARVEDILOL	3.125MG	TABLET / ORAL		2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077316-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077316-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077316-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 137 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077316-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077316-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077316-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077316-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077316-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077316-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077316-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077316-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077316-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077316-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077316-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077316-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077316-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077316-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077316-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077316-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077316-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077316-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077316-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077316-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077316-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077316-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077316-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077316-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077316-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077316-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077316-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077316-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077316-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077316-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077316-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077316-003	AB	1	`5d02ea3f76ae…`

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
47e33dcd-5231-6087-e063-6294a90aa9f9			b93697b3-c328-41b4-a012-13417bcc5169	2026-01-08		Exact identifier spl set id: b93697b3-c328-41b4-a012-13417bcc5169

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.