CARVEDILOL

Product NDC: 61919-533
Requested package NDC: 61919-533-90
11-digit product format: 619190533
Labeler code: 61919
Product ID: 61919-533_872365ca-0c2b-550a-e053-2a91aa0ab25a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CARVEDILOL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: DIRECT RX
Application: ANDA078384
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: CARVEDILOL
Active strength: 25 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: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61919-533	61919-533-90	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A078384-001	CARVEDILOL	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05
A078384-002	CARVEDILOL	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05
A078384-003	CARVEDILOL	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05
A078384-004	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
A078384-001	AB
A078384-002	AB
A078384-003	AB
A078384-004	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	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-001	CARVEDILOL	3.125MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-002	CARVEDILOL	6.25MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-003	CARVEDILOL	12.5MG	TABLET / ORAL	AB	2007-09-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-004	CARVEDILOL	25MG	TABLET / ORAL	AB	2007-09-05	`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	A078384-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078384-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078384-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078384-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078384-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078384-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078384-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078384-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078384-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078384-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078384-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078384-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078384-004	AB	1	`d8e5a09893c0…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61919-533-30	2025-01-31	CARVEDILOL
61919-533-90	2025-01-31	CARVEDILOL
61919-533-30	2024-01-30	CARVEDILOL
61919-533-90	2024-01-30	CARVEDILOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-533-30	CARVEDILOL	30 in 1 BOTTLE	TABLET, FILM COATED	30		3
61919-533-90	CARVEDILOL	90 in 1 BOTTLE	TABLET, FILM COATED	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-533-90	EA - Each	61919-533	7ff2a4f8-5177-4cc1-a63b-fd4657c86776	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARVEDILOL	ACTIVE INGREDIENT	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
CARVEDILOL	ACTIVE MOIETY	0K47UL67F2	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-533	CARVEDILOL TABLET, FILM COATED [DIRECT RX]	3	Legacy NDC, 2 package rows	20190423_d3992a3f-8347-476d-993e-16958c74efb3.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	cc3a9614-3017-4775-988e-6e5bd4621b70	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	45233e64-26ee-4117-a896-24363b435fc2	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	21191d89-16f6-49a8-9394-f31d0950deea	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Bryant Ranch Prepack	7aae1a4a-5d0e-4b19-9e4c-55707a9bb184	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Golden State Medical Supply, Inc.	454054f1-0730-41b3-844a-c7b65f1b47c5	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	UNICHEM PHARMACEUTICALS (USA), INC.	33dfcf29-19d6-46ba-b8ed-d59d2226ad07	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	df7415ac-e475-19c9-e053-2995a90afa71	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Northwind Health Company, LLC	db5d9e64-46b3-92d3-e053-2995a90a74bc	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Direct_Rx	462a9678-d2cd-d2b8-e063-6294a90a0139	2025-12-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Coupler LLC	441dda59-c3c4-d3c6-e063-6394a90a98dc	2025-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Proficient Rx LP	a1344411-fc64-4233-89ba-e90a1953e150	2025-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	NuCare Pharmaceuticals,Inc.	a7bfd0fc-054b-7397-e053-2a95a90ae3e2	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384
Carvedilol	CARVEDILOL	Aphena Pharma Solutions - Tennessee, LLC	e3f463b5-2743-4a4a-a90a-bf1ee10a5458	2018-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078384 application number: ANDA078384

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
200033	carvedilol 25 MG Oral Tablet	PSN	d3992a3f-8347-476d-993e-16958c74efb3	3
200033	carvedilol 25 MG Oral Tablet	SCD	d3992a3f-8347-476d-993e-16958c74efb3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-533-90	61919053390	90 TABLET, FILM COATED in 1 BOTTLE (61919-533-90)	2014-01-01	0000-00-00	No	No	Current