Carvedilol

Product NDC
63629-4060
11-digit product format
636294060
Labeler code
63629
Product ID
63629-4060_50f1e9cf-e25a-454d-acbb-113f4bdec411
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
3.125 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 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
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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077614-001CARVEDILOL6.25MGTABLET / 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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077614-004CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077614-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077614-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077614-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077614-004AB1d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL3.125 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
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
b23021d4-c00a-e0ef-eb93-1dc824ae56caAvailable 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
63629-4060-1Carvedilol30 in 1 BOTTLETABLET, FILM COATED3016
63629-4060-2Carvedilol100 in 1 BOTTLETABLET, FILM COATED10016
63629-4060-3Carvedilol180 in 1 BOTTLETABLET, FILM COATED18016
63629-4060-4Carvedilol60 in 1 BOTTLETABLET, FILM COATED6016
63629-4060-5Carvedilol90 in 1 BOTTLETABLET, FILM COATED9016
63629-4060-6Carvedilol120 in 1 BOTTLETABLET, FILM COATED12016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4060-1EA - Each63629-4060f8784a95-c4ca-4e01-85cd-90c89194f0e512012-07-24
63629-4060-2EA - Each63629-4060a575fca5-25f7-41c7-a53c-5267f6d1340f12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4060CARVEDILOL TABLET, FILM COATED [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 6 package rows20240511_b23021d4-c00a-e0ef-eb93-1dc824ae56ca.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
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
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
CarvedilolCARVEDILOLSt. Mary's Medical Park Pharmacy8a82149f-aade-2a9b-e053-2995a90a9daf2026-05-05Warnings, 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
ndc (product): 63629-4060
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
CarvedilolCARVEDILOLDirect_Rx4c0e089b-0199-43e2-e063-6394a90a78832026-03-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614
CarvedilolCARVEDILOLA-S Medication Solutions3eb4fd8e-1027-4d24-8f2f-12e9dcfe62312026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
686924carvedilol 3.125 MG Oral TabletPSNb23021d4-c00a-e0ef-eb93-1dc824ae56ca16
686924carvedilol 3.125 MG Oral TabletSCDb23021d4-c00a-e0ef-eb93-1dc824ae56ca16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4060-16362940600130 TABLET, FILM COATED in 1 BOTTLE (63629-4060-1) 2009-08-270000-00-00NoNoCurrent
63629-4060-263629406002100 TABLET, FILM COATED in 1 BOTTLE (63629-4060-2) 2009-09-040000-00-00NoNoCurrent
63629-4060-363629406003180 TABLET, FILM COATED in 1 BOTTLE (63629-4060-3) 2015-11-240000-00-00NoNoCurrent
63629-4060-46362940600460 TABLET, FILM COATED in 1 BOTTLE (63629-4060-4) 2011-05-020000-00-00NoNoCurrent
63629-4060-56362940600590 TABLET, FILM COATED in 1 BOTTLE (63629-4060-5) 2014-05-300000-00-00NoNoCurrent
63629-4060-663629406006120 TABLET, FILM COATED in 1 BOTTLE (63629-4060-6) 2014-10-280000-00-00NoNoCurrent