Carvedilol

Product NDC
71335-0273
Requested package NDC
71335-0273-5
11-digit product format
713350273
Labeler code
71335
Product ID
71335-0273_ade2e0f6-e1ba-482d-8eb7-df161ee703d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078332
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
2026-12-31
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-027371335-0273-5DDiscontinued by firm2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A078332-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A078332-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A078332-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A078332-004CARVEDILOLCARVEDILOL25MGTABLET / 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
A078332-001AB
A078332-002AB
A078332-003AB
A078332-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078332-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078332-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078332-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078332-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078332-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078332-004AB1d06236e962d9…

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
fe4aa7f0-6ef2-4a95-8a64-5e3365f10474Available 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
71335-0273-1Carvedilol100 in 1 BOTTLETABLET, FILM COATED100103
71335-0273-2Carvedilol30 in 1 BOTTLETABLET, FILM COATED30103
71335-0273-3Carvedilol90 in 1 BOTTLETABLET, FILM COATED90103
71335-0273-4Carvedilol60 in 1 BOTTLETABLET, FILM COATED60103
71335-0273-5Carvedilol120 in 1 BOTTLETABLET, FILM COATED120103
71335-0273-6Carvedilol180 in 1 BOTTLETABLET, FILM COATED180103
71335-0273-7Carvedilol10 in 1 BOTTLETABLET, FILM COATED10103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0273-3EA - Each71335-027308473b3c-6f1f-4f6f-b7f1-1c56bd9bfd3612018-09-05
71335-0273-4EA - Each71335-0273702efbe9-4bff-45b3-b9fa-2694d0a45e7012018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0273CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 7 package rows20240724_fe4aa7f0-6ef2-4a95-8a64-5e3365f10474.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.0930965b-80e3-4a0c-bffc-14ac32a478942025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.2be8635b-5733-1ed4-e054-00144ff88e882025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.8640adde-d071-44a4-97d0-fa8a8548debe2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.205da5d0-05d9-440d-bb5a-b30b826900ab2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLA-S Medication Solutionsf5969d18-46c7-4f35-9668-2fd4f6bbeb172025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLBryant Ranch Prepackfe4aa7f0-6ef2-4a95-8a64-5e3365f104742024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (package): 71335-0273-5
ndc (product): 71335-0273
ndc11 (package): 71335027305
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.786e8ad3-a8d7-41e6-e053-2991aa0a32c72024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLAurobindo Pharma Limited7cc14b86-0833-4c3c-91f3-7963d7052fd52024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LPcd7e7c34-6958-47be-a1c1-f1ed948e26872022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LP36230cc8-e808-4f74-a27d-4367eecd21f72022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LP55a19ff1-f8c1-4cf0-8711-9bfa32756de92020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLAphena Pharma Solutions - Tennessee, LLCd0089df4-37c8-41de-810c-14c9dc06f0c32018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSNfe4aa7f0-6ef2-4a95-8a64-5e3365f10474103
200033carvedilol 25 MG Oral TabletSCDfe4aa7f0-6ef2-4a95-8a64-5e3365f10474103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0273-571335027305120 TABLET, FILM COATED in 1 BOTTLE (71335-0273-5) 2024-07-090000-00-00NoNoCurrent