Carvedilol

Product NDC
0093-0135
11-digit product format
000930135
Labeler code
0093
Product ID
0093-0135_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
6.25 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
2026-12-31
Current FDA listing
Yes

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
A076373-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A076373-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A076373-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A076373-004CARVEDILOLCARVEDILOL25MGTABLET / ORALAB2007-09-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A076373-001AB
A076373-002AB
A076373-003AB
A076373-004AB

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 06:07:402026-07A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-05d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076373-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076373-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076373-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076373-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076373-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076373-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076373-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076373-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076373-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076373-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076373-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076373-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076373-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076373-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076373-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076373-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076373-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076373-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076373-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076373-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076373-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076373-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076373-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076373-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076373-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076373-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076373-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076373-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076373-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076373-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076373-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076373-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076373-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076373-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076373-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076373-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076373-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076373-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076373-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076373-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0K47UL67F2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200031Internal RxNorm lookup
200032Internal RxNorm lookup
200033Internal RxNorm lookup
686924Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
68c275e8-992a-4520-8065-ab6d615d89ccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-0135-01Carvedilol100 in 1 BOTTLETABLET, FILM COATED10016
0093-0135-05Carvedilol500 in 1 BOTTLETABLET, FILM COATED50016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-0135-01EA - Each0093-01354ef2379f-a6b5-49fc-b27e-45c97c73240512012-07-24
0093-0135-05EA - Each0093-0135e84c5b0d-972c-4d97-8d6a-832d9347631d12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-0135CARVEDILOL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, Legacy NDC, 2 package rows20240426_68c275e8-992a-4520-8065-ab6d615d89cc.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarvedilolCARVEDILOLA-S Medication Solutionsfe2d5c95-c101-4b01-89fd-0fd6d25ad80b2026-04-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076373
application number: ANDA076373
CarvedilolCARVEDILOLProficient Rx LP8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a2026-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076373
application number: ANDA076373
CarvedilolCARVEDILOLQPharma, Inc.ffbedcce-0d64-4aed-9e65-09448d71ca912025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076373
application number: ANDA076373
CarvedilolCARVEDILOLProficient Rx LP52785a22-ddca-4f5b-8579-5974df2a9a4e2025-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076373
application number: ANDA076373
CarvedilolCARVEDILOLNCS HealthCare of KY, LLC dba Vangard Labs2fb46fe1-9b7b-4718-9327-2471af22f0b72025-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076373
application number: ANDA076373
CarvedilolCARVEDILOLProficient Rx LPda2696ba-f4be-4626-9abe-fe33f36361b12025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076373
application number: ANDA076373
CarvedilolCARVEDILOLProficient Rx LPc0202d0f-2ffc-45f2-a98d-5f05ac1eaa852025-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076373
application number: ANDA076373
CarvedilolCARVEDILOLTeva Pharmaceuticals USA, Inc.68c275e8-992a-4520-8065-ab6d615d89cc2024-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076373
application number: ANDA076373
ndc (product): 0093-0135

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN68c275e8-992a-4520-8065-ab6d615d89cc16
200033carvedilol 25 MG Oral TabletPSN68c275e8-992a-4520-8065-ab6d615d89cc16
686924carvedilol 3.125 MG Oral TabletPSN68c275e8-992a-4520-8065-ab6d615d89cc16
200031carvedilol 6.25 MG Oral TabletPSN68c275e8-992a-4520-8065-ab6d615d89cc16
200032carvedilol 12.5 MG Oral TabletSCD68c275e8-992a-4520-8065-ab6d615d89cc16
200033carvedilol 25 MG Oral TabletSCD68c275e8-992a-4520-8065-ab6d615d89cc16
686924carvedilol 3.125 MG Oral TabletSCD68c275e8-992a-4520-8065-ab6d615d89cc16
200031carvedilol 6.25 MG Oral TabletSCD68c275e8-992a-4520-8065-ab6d615d89cc16
200032carvedilol 12.5 MG Oral TabletPSN2fb46fe1-9b7b-4718-9327-2471af22f0b78
200033carvedilol 25 MG Oral TabletPSN2fb46fe1-9b7b-4718-9327-2471af22f0b78
686924carvedilol 3.125 MG Oral TabletPSN2fb46fe1-9b7b-4718-9327-2471af22f0b78
200031carvedilol 6.25 MG Oral TabletPSN2fb46fe1-9b7b-4718-9327-2471af22f0b78
200032carvedilol 12.5 MG Oral TabletSCD2fb46fe1-9b7b-4718-9327-2471af22f0b78
200033carvedilol 25 MG Oral TabletSCD2fb46fe1-9b7b-4718-9327-2471af22f0b78
686924carvedilol 3.125 MG Oral TabletSCD2fb46fe1-9b7b-4718-9327-2471af22f0b78
200031carvedilol 6.25 MG Oral TabletSCD2fb46fe1-9b7b-4718-9327-2471af22f0b78
200031carvedilol 6.25 MG Oral TabletPSN8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a1
200031carvedilol 6.25 MG Oral TabletSCD8db9cddd-0ee7-4ce8-a8c9-c5e043b2838a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-0135-0100093013501100 TABLET, FILM COATED in 1 BOTTLE (0093-0135-01) 2007-09-060000-00-00NoNoCurrent
0093-0135-0500093013505500 TABLET, FILM COATED in 1 BOTTLE (0093-0135-05) 2008-12-020000-00-00NoNoCurrent