CARVEDILOL

Product NDC
72888-037
11-digit product format
728880037
Labeler code
72888
Product ID
72888-037_4b7db91d-a37b-1e8e-e063-6394a90ab2cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA078165
Marketing category
ANDA
Marketing start
2021-07-29
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
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
A078165-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A078165-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A078165-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A078165-004CARVEDILOLCARVEDILOL25MGTABLET / 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
A078165-001AB
A078165-002AB
A078165-003AB
A078165-004AB

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 06:07:402026-07A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078165-004CARVEDILOL25MGTABLET / 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 06:07:402026-07A078165-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078165-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078165-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078165-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078165-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078165-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078165-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078165-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078165-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078165-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078165-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078165-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078165-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078165-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078165-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078165-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078165-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078165-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078165-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078165-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078165-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078165-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078165-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078165-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078165-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078165-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078165-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078165-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078165-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078165-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078165-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078165-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078165-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078165-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078165-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078165-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078165-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078165-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078165-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078165-004AB1d8e5a09893c0…

Additional Listing Data#

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

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 · 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
7a7d3ca1-05b0-4c7e-aefa-492cc441585dAvailable 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
72888-037-00CARVEDILOL1000 in 1 BOTTLETABLET, FILM COATED10003
72888-037-01CARVEDILOL100 in 1 BOTTLETABLET, FILM COATED1003
72888-037-05CARVEDILOL500 in 1 BOTTLETABLET, FILM COATED5003
72888-037-30CARVEDILOL30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-037-00EA - Each72888-03727841533-da73-47c8-aab1-dfd82353d0bd12021-10-08
72888-037-01EA - Each72888-037b69d8efa-2f40-48a8-8fa5-17c4615e47ca12021-11-09
72888-037-05EA - Each72888-037a4e2d3f3-4ffa-42fa-9ee8-d8069797050b12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-037CARVEDILOL TABLET, FILM COATED [ADVAGEN PHARMA LTD]1Current NDC, Legacy NDC, 4 package rows20210818_7a7d3ca1-05b0-4c7e-aefa-492cc441585d.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARVEDILOLCARVEDILOLPD-Rx Pharmaceuticals, Inc.95300809-be15-461e-904e-b56aba6769752026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLPD-Rx Pharmaceuticals, Inc.9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa92026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLNuCare Pharmaceuticals, Inc.574c419f-3b9e-2171-e063-6394a90a0e902026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLBryant Ranch Prepack03b7c07c-14ba-40c8-8c0a-8dfa4a10f5802026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLBryant Ranch Prepackfe462198-32ae-4f6c-befc-acb97fb017c92026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLBryant Ranch Prepack1ddff189-1848-4186-bca9-063e4ea7fd1f2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLNuCare Pharmaceuticals, Inc.4bbf3767-8666-22d8-e063-6294a90a2afe2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLAdvagen Pharma Ltd7a7d3ca1-05b0-4c7e-aefa-492cc441585d2026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
ndc (product): 72888-037
CARVEDILOLCARVEDILOLA-S Medication Solutions5eeeaeee-9698-493f-9aa7-d130681472082026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLA-S Medication Solutions947baca7-f9c8-4821-b47b-53c45288613e2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLPreferred Pharmaceuticals Inc.8d3937b4-e0dd-4165-9825-bbf5020d79f92025-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLRedPharm Drug, Incfcb1de7c-1878-1835-e053-6294a90abe952025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLRedPharm Drug, Incfcb2025f-11a1-ea73-e053-6394a90a61cb2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSN1ddff189-1848-4186-bca9-063e4ea7fd1f103
200033carvedilol 25 MG Oral TabletSCD1ddff189-1848-4186-bca9-063e4ea7fd1f103
200033carvedilol 25 MG Oral TabletPSN9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa96
200033carvedilol 25 MG Oral TabletSCD9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa96
200033carvedilol 25 MG Oral TabletPSN8d3937b4-e0dd-4165-9825-bbf5020d79f94
200033carvedilol 25 MG Oral TabletSCD8d3937b4-e0dd-4165-9825-bbf5020d79f94
200032carvedilol 12.5 MG Oral TabletPSN7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200033carvedilol 25 MG Oral TabletPSN7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
686924carvedilol 3.125 MG Oral TabletPSN7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200031carvedilol 6.25 MG Oral TabletPSN7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200032carvedilol 12.5 MG Oral TabletSCD7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200033carvedilol 25 MG Oral TabletSCD7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
686924carvedilol 3.125 MG Oral TabletSCD7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200031carvedilol 6.25 MG Oral TabletSCD7a7d3ca1-05b0-4c7e-aefa-492cc441585d3
200033carvedilol 25 MG Oral TabletPSNfcb1de7c-1878-1835-e053-6294a90abe952
200033carvedilol 25 MG Oral TabletPSNfcb2025f-11a1-ea73-e053-6394a90a61cb2
200033carvedilol 25 MG Oral TabletSCDfcb1de7c-1878-1835-e053-6294a90abe952
200033carvedilol 25 MG Oral TabletSCDfcb2025f-11a1-ea73-e053-6394a90a61cb2
200033carvedilol 25 MG Oral TabletPSN947baca7-f9c8-4821-b47b-53c45288613e1
200033carvedilol 25 MG Oral TabletPSN5eeeaeee-9698-493f-9aa7-d130681472081
200033carvedilol 25 MG Oral TabletSCD947baca7-f9c8-4821-b47b-53c45288613e1
200033carvedilol 25 MG Oral TabletSCD5eeeaeee-9698-493f-9aa7-d130681472081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-037-00728880037001000 TABLET, FILM COATED in 1 BOTTLE (72888-037-00) 2021-07-290000-00-00NoNoCurrent
72888-037-0172888003701100 TABLET, FILM COATED in 1 BOTTLE (72888-037-01) 2021-07-290000-00-00NoNoCurrent
72888-037-0572888003705500 TABLET, FILM COATED in 1 BOTTLE (72888-037-05) 2021-07-290000-00-00NoNoCurrent
72888-037-307288800373030 TABLET, FILM COATED in 1 BOTTLE (72888-037-30) 2021-07-290000-00-00NoNoCurrent