Carvedilol

Product NDC
57664-244
11-digit product format
576640244
Labeler code
57664
Product ID
57664-244_231b19c0-5ee3-33c1-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077346
Marketing category
ANDA
Marketing start
2007-09-05
Marketing end
0000-00-00
Substance
CARVEDILOL
Active strength
6 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
2019-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57664-244DDiscontinued by firm2026-10-05
excluded productproduct57664-244DDiscontinued by firm2026-10-05
excluded packagepackage57664-24457664-244-13DDiscontinued by firm2026-10-05
excluded packagepackage57664-24457664-244-18DDiscontinued by firm2026-10-05
excluded packagepackage57664-24457664-244-88DDiscontinued by firm2026-10-05
excluded packagepackage57664-24457664-244-13DDiscontinued by firm2026-10-05
excluded packagepackage57664-24457664-244-18DDiscontinued by firm2026-10-05
excluded packagepackage57664-24457664-244-88DDiscontinued by firm2026-10-05

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 2 · 96 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-244-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-244-18d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-244-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-244-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-244-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57664-244-18d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-244-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-244-18f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-244-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-244-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-244-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-244-18f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-244-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-244-182ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-244-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-244-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-244-882ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage57664-244-182ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-244-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-244-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-244-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-244-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-244-88a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage57664-244-18a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-244-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-244-18cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-244-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-244-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-244-88cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage57664-244-18cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-244-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-244-18cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-244-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-244-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-244-88cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage57664-244-18cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-244-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-244-18302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-244-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-244-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-244-88302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage57664-244-18302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-244-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage57664-244-18ed331223b511…672a5bd82f5f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077346-001CARVEDILOLCARVEDILOL6.25MGTABLET / ORAL2007-09-05
A077346-002CARVEDILOLCARVEDILOL12.5MGTABLET / ORAL2007-09-05
A077346-003CARVEDILOLCARVEDILOL25MGTABLET / ORAL2007-09-05
A077346-004CARVEDILOLCARVEDILOL3.125MGTABLET / ORAL2007-09-05

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-0584e616aacf4f…
2026-08-18 06:07:402026-07A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077346-001CARVEDILOL6.25MGTABLET / ORAL2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077346-002CARVEDILOL12.5MGTABLET / ORAL2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077346-003CARVEDILOL25MGTABLET / ORAL2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077346-004CARVEDILOL3.125MGTABLET / ORAL2007-09-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A077346-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077346-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077346-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077346-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077346-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077346-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077346-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077346-004AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-244-13EA - Each57664-2440d33f535-c5b8-4e84-8a44-c3800744fa4312012-07-24
57664-244-18EA - Each57664-244b7b372ed-81ca-4fa4-8d6b-0b6138ea22ff12012-07-24
57664-244-88EA - Each57664-244c0b3418b-d8ee-4c7f-b004-6ebd1830e5ff12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
MANNITOLINACTIVE INGREDIENT3OWL53L36ACARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
POVIDONEINACTIVE INGREDIENTFZ989GH94ECARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
TALCINACTIVE INGREDIENT7SEV7J4R1UCARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13