Carvedilol

Product NDC
71335-1623
11-digit product format
713351623
Labeler code
71335
Product ID
71335-1623_35711bc7-16ba-4eb1-9ccc-b8e1bcf67ccd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077614
Marketing category
ANDA
Marketing start
2007-09-05
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
2027-12-31
Current FDA listing
Yes

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
A077614-001CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A077614-002CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A077614-003CARVEDILOLCARVEDILOL25MGTABLET / ORALAB2007-09-05
A077614-004CARVEDILOLCARVEDILOL3.125MGTABLET / 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
A077614-001AB
A077614-002AB
A077614-003AB
A077614-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-09-14 22:38:342026-08A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-0584e616aacf4f…
2026-08-18 06:07:402026-07A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077614-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077614-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077614-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A077614-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A077614-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077614-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077614-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077614-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077614-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077614-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077614-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077614-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077614-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077614-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077614-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077614-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077614-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077614-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077614-004AB15bbf6a4d5a75…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL25 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 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
196536eb-8b94-45da-a2f3-f554d6bf88e9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1623-1Carvedilol100 in 1 BOTTLETABLET, FILM COATED1004
71335-1623-2Carvedilol30 in 1 BOTTLETABLET, FILM COATED304
71335-1623-3Carvedilol90 in 1 BOTTLETABLET, FILM COATED904
71335-1623-4Carvedilol60 in 1 BOTTLETABLET, FILM COATED604
71335-1623-5Carvedilol120 in 1 BOTTLETABLET, FILM COATED1204
71335-1623-6Carvedilol180 in 1 BOTTLETABLET, FILM COATED1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1623CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 6 package rows20240502_196536eb-8b94-45da-a2f3-f554d6bf88e9.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 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarvedilolCARVEDILOLREMEDYREPACK INC.d7d6bfff-fbb6-4a1f-aa13-babbb9a1e8782026-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLSt. Mary's Medical Park Pharmacy8a82149f-aade-2a9b-e053-2995a90a9daf2026-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLBryant Ranch Prepackc5b907f8-84a0-5fb2-e7ec-4c82246195f52026-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLCoupler LLC58280d18-5960-1730-e063-6394a90a4f642026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLREMEDYREPACK INC.ab8aa773-0ed1-4d59-a1bb-f46cf882644f2026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLREMEDYREPACK INC.0e98593a-8424-48c8-acc0-671f4b566aee2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLREMEDYREPACK INC.32098c09-7580-4975-a3e1-31b619c04c692026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLBryant Ranch Prepack196536eb-8b94-45da-a2f3-f554d6bf88e92026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
ndc (product): 71335-1623
CarvedilolCARVEDILOLREMEDYREPACK INC.683bd1c4-fb9d-46cc-9bd4-6a6e455cadfb2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLREMEDYREPACK INC.39cf31cc-8f3d-4919-a93a-f997ad6850dc2026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLREMEDYREPACK INC.6eec3476-f6db-45bd-bb91-4b2d5fbd0f5f2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLSt. Mary's Medical Park Pharmacyed11cd4e-d7c9-8446-e053-2995a90afd6e2026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLCoupler LLC52bd1d20-08ba-1e5e-e063-6294a90ae8a92026-05-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLCoupler LLC51b403dc-fc9f-0cad-e063-6394a90af0812026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLQPharma Inc010290af-81f4-0037-e063-6394a90a46382026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLBryant Ranch Prepackb23021d4-c00a-e0ef-eb93-1dc824ae56ca2026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLPreferred Pharmaceuticals, Inc.5c34847d-68f9-4967-81c8-a2297a6acb7f2026-03-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLPreferred Pharmaceuticals Inc.3b56e0d0-82d7-4512-849f-2b72d7bae36e2026-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLBluePoint Laboratoriese68c9b18-e7fd-45f7-a8f5-1d815e32680b2026-03-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLDirect_Rx4c48ba6b-4e1e-5116-e063-6394a90aa7932026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN196536eb-8b94-45da-a2f3-f554d6bf88e94
200033carvedilol 25 MG Oral TabletPSN196536eb-8b94-45da-a2f3-f554d6bf88e94
200032carvedilol 12.5 MG Oral TabletSCD196536eb-8b94-45da-a2f3-f554d6bf88e94
200033carvedilol 25 MG Oral TabletSCD196536eb-8b94-45da-a2f3-f554d6bf88e94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1623-171335162301100 TABLET, FILM COATED in 1 BOTTLE (71335-1623-1) 2007-09-050000-00-00NoNoCurrent
71335-1623-27133516230230 TABLET, FILM COATED in 1 BOTTLE (71335-1623-2) 2007-09-050000-00-00NoNoCurrent
71335-1623-37133516230390 TABLET, FILM COATED in 1 BOTTLE (71335-1623-3) 2007-09-050000-00-00NoNoCurrent
71335-1623-47133516230460 TABLET, FILM COATED in 1 BOTTLE (71335-1623-4) 2007-09-050000-00-00NoNoCurrent
71335-1623-571335162305120 TABLET, FILM COATED in 1 BOTTLE (71335-1623-5) 2007-09-050000-00-00NoNoCurrent
71335-1623-671335162306180 TABLET, FILM COATED in 1 BOTTLE (71335-1623-6) 2007-09-050000-00-00NoNoCurrent
71335-1623-77133516230710 TABLET, FILM COATED in 1 BOTTLE (71335-1623-7) 2007-09-05NoNoCurrent