FDA.reportPublic FDA data

Carvedilol

Product NDC
50090-5115
11-digit product format
500905115
Labeler code
50090
Product ID
50090-5115_835b01c6-d2bf-41a4-a96a-1a8077bddc3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076373
Marketing category
ANDA
Marketing start
2007-09-06
Marketing end
0000-00-00
Substance
CARVEDILOL
Active strength
13 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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-5115IInactivated by FDA2026-08-03
excluded packagepackage50090-511550090-5115-0IInactivated by FDA2026-08-03
excluded packagepackage50090-511550090-5115-1IInactivated by FDA2026-08-03

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076373-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05a50c72e98297…
2026-08-01 22:54:322026-06A076373-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05a50c72e98297…
2026-08-01 22:54:322026-06A076373-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05a50c72e98297…
2026-08-01 22:54:322026-06A076373-004CARVEDILOL25MGTABLET / ORALAB2007-09-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076373-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A076373-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A076373-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A076373-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5115-02023-01-30C16284748780-1f386c649-db17-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
50090-5115-12023-01-30C16284748780-1f386c649-db17-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5115-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED603
50090-5115-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5115CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_52a672a8-db98-4acf-99d5-62eb2977e767.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN52a672a8-db98-4acf-99d5-62eb2977e7673
200032carvedilol 12.5 MG Oral TabletSCD52a672a8-db98-4acf-99d5-62eb2977e7673

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5115-05009051150060 TABLET, FILM COATED in 1 BOTTLE (50090-5115-0) 2020-07-310000-00-00NoNoCurrent
50090-5115-150090511501180 TABLET, FILM COATED in 1 BOTTLE (50090-5115-1) 2020-07-310000-00-00NoNoCurrent