Carvedilol

Product NDC
76385-110
11-digit product format
763850110
Labeler code
76385
Product ID
76385-110_4aa597d4-9141-4bef-a4d5-03b111958338
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
UNICHEM PHARMACEUTICALS (USA), INC.
Application
ANDA078384
Marketing category
ANDA
Marketing start
2016-10-01
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
A078384-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A078384-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A078384-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A078384-004CARVEDILOLCARVEDILOL25MGTABLET / 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
A078384-001AB
A078384-002AB
A078384-003AB
A078384-004AB

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 06:07:402026-07A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078384-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078384-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078384-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078384-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078384-004CARVEDILOL25MGTABLET / 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 06:07:402026-07A078384-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078384-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078384-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078384-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078384-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078384-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078384-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078384-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078384-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078384-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078384-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078384-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078384-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078384-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078384-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078384-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078384-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078384-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078384-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078384-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078384-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078384-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078384-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078384-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078384-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078384-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078384-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078384-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078384-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078384-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078384-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078384-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078384-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078384-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078384-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078384-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078384-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078384-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078384-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078384-004AB1d8e5a09893c0…

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 · 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
33dfcf29-19d6-46ba-b8ed-d59d2226ad07Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e148a93c-bfff-2735-e6c0-0739297b4596Product name320180705
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
32d6365f-9f0e-0782-b719-48e651893fb7Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76385-110-01Carvedilol100 in 1 BOTTLE, PLASTICTablet, FILM COATED1008
76385-110-50Carvedilol500 in 1 BOTTLE, PLASTICTablet, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76385-110-01EA - Each76385-1105249fb75-eb72-4de7-b3f3-49ede76e9acd12016-10-06
76385-110-50EA - Each76385-110742f86ba-76cd-4638-9507-075c65d3b52b12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76385-110CARVEDILOL TABLET, FILM COATED [BAYSHORE PHARMACEUTICALS LLC]7Current NDC, Legacy NDC, 2 package rows20240614_33dfcf29-19d6-46ba-b8ed-d59d2226ad07.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
CarvedilolCARVEDILOLBryant Ranch Prepackcc3a9614-3017-4775-988e-6e5bd4621b702026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLBryant Ranch Prepack45233e64-26ee-4117-a896-24363b435fc22026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLBryant Ranch Prepack21191d89-16f6-49a8-9394-f31d0950deea2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLBryant Ranch Prepack7aae1a4a-5d0e-4b19-9e4c-55707a9bb1842026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLGolden State Medical Supply, Inc.454054f1-0730-41b3-844a-c7b65f1b47c52026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLUNICHEM PHARMACEUTICALS (USA), INC.33dfcf29-19d6-46ba-b8ed-d59d2226ad072026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
ndc (product): 76385-110
CarvedilolCARVEDILOLNorthwind Health Company, LLCdf7415ac-e475-19c9-e053-2995a90afa712026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLNorthwind Health Company, LLCdb5d9e64-46b3-92d3-e053-2995a90a74bc2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLDirect_Rx462a9678-d2cd-d2b8-e063-6294a90a01392025-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLCoupler LLC441dda59-c3c4-d3c6-e063-6394a90a98dc2025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLProficient Rx LPa1344411-fc64-4233-89ba-e90a1953e1502025-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.a7bfd0fc-054b-7397-e053-2a95a90ae3e22024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384
CarvedilolCARVEDILOLAphena Pharma Solutions - Tennessee, LLCe3f463b5-2743-4a4a-a90a-bf1ee10a54582018-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078384
application number: ANDA078384

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSN454054f1-0730-41b3-844a-c7b65f1b47c511
200033carvedilol 25 MG Oral TabletPSN454054f1-0730-41b3-844a-c7b65f1b47c511
686924carvedilol 3.125 MG Oral TabletPSN454054f1-0730-41b3-844a-c7b65f1b47c511
200031carvedilol 6.25 MG Oral TabletPSN454054f1-0730-41b3-844a-c7b65f1b47c511
200032carvedilol 12.5 MG Oral TabletSCD454054f1-0730-41b3-844a-c7b65f1b47c511
200033carvedilol 25 MG Oral TabletSCD454054f1-0730-41b3-844a-c7b65f1b47c511
686924carvedilol 3.125 MG Oral TabletSCD454054f1-0730-41b3-844a-c7b65f1b47c511
200031carvedilol 6.25 MG Oral TabletSCD454054f1-0730-41b3-844a-c7b65f1b47c511
200032carvedilol 12.5 MG Oral TabletPSN33dfcf29-19d6-46ba-b8ed-d59d2226ad078
200033carvedilol 25 MG Oral TabletPSN33dfcf29-19d6-46ba-b8ed-d59d2226ad078
686924carvedilol 3.125 MG Oral TabletPSNcc3a9614-3017-4775-988e-6e5bd4621b708
686924carvedilol 3.125 MG Oral TabletPSN33dfcf29-19d6-46ba-b8ed-d59d2226ad078
200031carvedilol 6.25 MG Oral TabletPSN33dfcf29-19d6-46ba-b8ed-d59d2226ad078
200032carvedilol 12.5 MG Oral TabletSCD33dfcf29-19d6-46ba-b8ed-d59d2226ad078
200033carvedilol 25 MG Oral TabletSCD33dfcf29-19d6-46ba-b8ed-d59d2226ad078
686924carvedilol 3.125 MG Oral TabletSCDcc3a9614-3017-4775-988e-6e5bd4621b708
686924carvedilol 3.125 MG Oral TabletSCD33dfcf29-19d6-46ba-b8ed-d59d2226ad078
200031carvedilol 6.25 MG Oral TabletSCD33dfcf29-19d6-46ba-b8ed-d59d2226ad078
686924carvedilol 3.125 MG Oral TabletPSNdb5d9e64-46b3-92d3-e053-2995a90a74bc5
686924carvedilol 3.125 MG Oral TabletSCDdb5d9e64-46b3-92d3-e053-2995a90a74bc5
686924carvedilol 3.125 MG Oral TabletPSN462a9678-d2cd-d2b8-e063-6294a90a01391
686924carvedilol 3.125 MG Oral TabletPSN441dda59-c3c4-d3c6-e063-6394a90a98dc1
686924carvedilol 3.125 MG Oral TabletPSNd6f8af0e-660e-191c-e053-2995a90a45fc1
686924carvedilol 3.125 MG Oral TabletSCD462a9678-d2cd-d2b8-e063-6294a90a01391
686924carvedilol 3.125 MG Oral TabletSCD441dda59-c3c4-d3c6-e063-6394a90a98dc1
686924carvedilol 3.125 MG Oral TabletSCDd6f8af0e-660e-191c-e053-2995a90a45fc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76385-110-0176385011001100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-110-01) 2016-10-010000-00-00NoNoCurrent
76385-110-5076385011050500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76385-110-50) 2016-10-010000-00-00NoNoCurrent