Carvedilol

Product NDC
58657-752
11-digit product format
586570752
Labeler code
58657
Product ID
58657-752_41b3fac8-087e-fa78-e063-6294a90a75e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Method Pharmaceuticals, LLC
Application
ANDA078786
Marketing category
ANDA
Marketing start
2024-12-03
Substance
CARVEDILOL
Active strength
12.5 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
A078786-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2009-12-22
A078786-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2009-12-22
A078786-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2009-12-22
A078786-004CARVEDILOLCARVEDILOL25MGTABLET / ORALAB2009-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078786-001AB
A078786-002AB
A078786-003AB
A078786-004AB

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 06:07:402026-07A078786-001CARVEDILOL3.125MGTABLET / ORALAB2009-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A078786-002CARVEDILOL6.25MGTABLET / ORALAB2009-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A078786-003CARVEDILOL12.5MGTABLET / ORALAB2009-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07A078786-004CARVEDILOL25MGTABLET / ORALAB2009-12-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078786-001CARVEDILOL3.125MGTABLET / ORALAB2009-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078786-002CARVEDILOL6.25MGTABLET / ORALAB2009-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078786-003CARVEDILOL12.5MGTABLET / ORALAB2009-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078786-004CARVEDILOL25MGTABLET / ORALAB2009-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078786-001CARVEDILOL3.125MGTABLET / ORALAB2009-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078786-002CARVEDILOL6.25MGTABLET / ORALAB2009-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078786-003CARVEDILOL12.5MGTABLET / ORALAB2009-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078786-004CARVEDILOL25MGTABLET / ORALAB2009-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A078786-001CARVEDILOL3.125MGTABLET / ORALAB2009-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078786-002CARVEDILOL6.25MGTABLET / ORALAB2009-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078786-003CARVEDILOL12.5MGTABLET / ORALAB2009-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078786-004CARVEDILOL25MGTABLET / ORALAB2009-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078786-001CARVEDILOL3.125MGTABLET / ORALAB2009-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078786-002CARVEDILOL6.25MGTABLET / ORALAB2009-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078786-003CARVEDILOL12.5MGTABLET / ORALAB2009-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078786-004CARVEDILOL25MGTABLET / ORALAB2009-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078786-001CARVEDILOL3.125MGTABLET / ORALAB2009-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078786-002CARVEDILOL6.25MGTABLET / ORALAB2009-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078786-003CARVEDILOL12.5MGTABLET / ORALAB2009-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078786-004CARVEDILOL25MGTABLET / ORALAB2009-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078786-001CARVEDILOL3.125MGTABLET / ORALAB2009-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078786-002CARVEDILOL6.25MGTABLET / ORALAB2009-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078786-003CARVEDILOL12.5MGTABLET / ORALAB2009-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078786-004CARVEDILOL25MGTABLET / ORALAB2009-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078786-001CARVEDILOL3.125MGTABLET / ORALAB2009-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078786-002CARVEDILOL6.25MGTABLET / ORALAB2009-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078786-003CARVEDILOL12.5MGTABLET / ORALAB2009-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078786-004CARVEDILOL25MGTABLET / ORALAB2009-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078786-001CARVEDILOL3.125MGTABLET / ORAL2009-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078786-002CARVEDILOL6.25MGTABLET / ORAL2009-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078786-003CARVEDILOL12.5MGTABLET / ORAL2009-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078786-004CARVEDILOL25MGTABLET / ORAL2009-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078786-001CARVEDILOL3.125MGTABLET / ORAL2009-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078786-002CARVEDILOL6.25MGTABLET / ORAL2009-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078786-003CARVEDILOL12.5MGTABLET / ORAL2009-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078786-004CARVEDILOL25MGTABLET / ORAL2009-12-22d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A078786-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078786-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078786-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078786-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078786-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078786-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078786-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078786-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078786-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078786-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078786-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078786-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078786-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078786-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078786-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078786-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078786-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078786-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078786-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078786-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078786-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078786-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078786-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078786-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078786-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078786-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078786-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078786-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078786-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078786-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078786-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078786-004AB12680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078786-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078786-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078786-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078786-004AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL12.5 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
a6ab5da0-8f22-491d-b007-85d9d4901828Available 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
58657-752-01Carvedilol100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
58657-752-50Carvedilol500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-752CARVEDILOL TABLET, FILM COATED [METHOD PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20241212_a6ab5da0-8f22-491d-b007-85d9d4901828.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarvedilolCARVEDILOLAdvagen Pharma Limited205291ba-86a7-43e1-be47-bc75df1921f92026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078786
application number: ANDA078786
CarvedilolCARVEDILOLMethod Pharmaceuticals, LLCa6ab5da0-8f22-491d-b007-85d9d49018282025-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078786
application number: ANDA078786
ndc (product): 58657-752

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNa6ab5da0-8f22-491d-b007-85d9d49018283
200033carvedilol 25 MG Oral TabletPSNa6ab5da0-8f22-491d-b007-85d9d49018283
686924carvedilol 3.125 MG Oral TabletPSNa6ab5da0-8f22-491d-b007-85d9d49018283
200031carvedilol 6.25 MG Oral TabletPSNa6ab5da0-8f22-491d-b007-85d9d49018283
200032carvedilol 12.5 MG Oral TabletSCDa6ab5da0-8f22-491d-b007-85d9d49018283
200033carvedilol 25 MG Oral TabletSCDa6ab5da0-8f22-491d-b007-85d9d49018283
686924carvedilol 3.125 MG Oral TabletSCDa6ab5da0-8f22-491d-b007-85d9d49018283
200031carvedilol 6.25 MG Oral TabletSCDa6ab5da0-8f22-491d-b007-85d9d49018283

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58657-752-0158657075201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58657-752-01) 2024-12-03NoNoCurrent
58657-752-5058657075250500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58657-752-50) 2024-12-03NoNoCurrent