Carvedilol

Product NDC
55154-5676
11-digit product format
551545676
Labeler code
55154
Product ID
55154-5676_047065cc-d470-4b94-b65f-4ce62eb49f12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA077316
Marketing category
ANDA
Marketing start
2011-02-18
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
2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-5676DDiscontinued by firm2026-08-17
excluded packagepackage55154-567655154-5676-0DDiscontinued by firm2026-08-17

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 · 4 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 packagepackage55154-5676-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55154-5676-0f5e01cc5f278…a2eaf40c39c3…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077316-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORAL2007-09-05
A077316-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORAL2007-09-05
A077316-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORAL2007-09-05
A077316-004CARVEDILOLCARVEDILOL25MGTABLET / 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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077316-002CARVEDILOL6.25MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077316-003CARVEDILOL12.5MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077316-004CARVEDILOL25MGTABLET / ORAL2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-001CARVEDILOL3.125MGTABLET / ORAL2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-004CARVEDILOL25MGTABLET / ORALAB2007-09-05d8e5a09893c0…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077316-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077316-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077316-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077316-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077316-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077316-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077316-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077316-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077316-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077316-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077316-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077316-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077316-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077316-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077316-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077316-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077316-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077316-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077316-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077316-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077316-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077316-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077316-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077316-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077316-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077316-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077316-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077316-003AB15d02ea3f76ae…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-5676-0EA - Each55154-5676eec3629b-ea13-4f71-8fdb-cd26409a616012017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [CARDINAL HEALTH]15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5676-05515456760010 BLISTER PACK in 1 BAG (55154-5676-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2011-02-180000-00-00NoNoCurrent