FDA.reportPublic FDA data

Carvedilol

Product NDC
66116-361
11-digit product format
661160361
Labeler code
66116
Product ID
66116-361_b4647b22-9a70-4259-a8f6-fac0ce1ac5c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
Application
ANDA076373
Marketing category
ANDA
Marketing start
2011-09-13
Marketing end
0000-00-00
Substance
CARVEDILOL
Active strength
3 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
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66116-361IInactivated by FDA2026-08-03
excluded packagepackage66116-36166116-361-60IInactivated 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
66116-361-602019-11-13C16284748780-197449f38-bde6-f6ea-e053-dbdaa90aa703These highlights do not include all the information needed to use carvedilol tablets USP safely and effectively. See full prescribing information for carvedilol tablets USP. CARVEDILOL tablets USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-361-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-361CARVEDILOL TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20111110_b4647b22-9a70-4259-a8f6-fac0ce1ac5c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSNb4647b22-9a70-4259-a8f6-fac0ce1ac5c51
686924carvedilol 3.125 MG Oral TabletSCDb4647b22-9a70-4259-a8f6-fac0ce1ac5c51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66116-361-606611603616060 in 1 BOTTLEHistorical