Carvedilol

Product NDC
68071-4816
11-digit product format
680714816
Labeler code
68071
Product ID
68071-4816_4baef540-88e7-30f4-e063-6294a90acf51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078251
Marketing category
ANDA
Marketing start
2007-09-05
Substance
CARVEDILOL
Active strength
6.25 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4816-88af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4816-8834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4816-81332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68071-4816-8fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68071-4816-886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68071-4816-8bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68071-4816-88dfbde2a14a4…c9ff85d89658…

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
A078251-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A078251-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A078251-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A078251-004CARVEDILOLCARVEDILOL25MGTABLET / 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
A078251-001AB
A078251-002AB
A078251-003AB
A078251-004AB

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-05d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078251-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078251-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078251-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078251-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078251-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078251-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078251-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078251-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078251-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078251-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078251-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078251-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078251-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078251-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078251-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078251-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078251-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078251-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078251-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078251-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078251-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078251-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078251-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078251-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078251-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078251-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078251-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078251-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078251-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078251-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078251-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078251-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078251-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078251-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078251-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078251-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078251-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078251-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078251-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078251-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL6.25 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
200031Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
84ee5fbf-7299-4b8a-e053-2a91aa0aa159Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4816-3Carvedilol30 in 1 BOTTLETABLET, FILM COATED303
68071-4816-8Carvedilol180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4816CARVEDILOL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20240616_84ee5fbf-7299-4b8a-e053-2a91aa0aa159.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CarvedilolCARVEDILOLMajor Pharmaceuticalsec6d8d73-9d18-4a9e-ae0c-0ea12059e78e2026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLBryant Ranch Prepackb4e700f8-d0e0-4ad5-93b5-e935389a96e32026-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLBryant Ranch Prepackd7669550-adcc-4e70-83b1-c28ce75e7fda2026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLCardinal Health 107, LLCbd0f2596-a192-4b0e-836f-4a09816408a42026-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.e285434f-d831-b6e7-e053-2995a90a1ab22026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.84ee5fbf-7299-4b8a-e053-2a91aa0aa1592026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
ndc (product): 68071-4816
CarvedilolCARVEDILOLA-S Medication Solutionsee848543-12fb-446c-86db-bf2322ec986f2026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLA-S Medication Solutions3c8d54e6-835c-4fa7-b13b-b798916cfed32026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLNorthwind Health Company, LLCc133b9c7-ab1a-e517-e053-2995a90a517a2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLGlenmark Pharmaceuticals Inc., USAc4a21f67-7812-4634-beba-f8e85c63c5f22025-10-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLA-S Medication Solutionse0ae5bed-1cb4-45d6-befe-dfc68edb9b342023-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
CarvedilolCARVEDILOLProficient Rx LPc03bd9d7-1e0b-49da-a14a-32e712dc3a2d2021-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSN84ee5fbf-7299-4b8a-e053-2a91aa0aa1593
200031carvedilol 6.25 MG Oral TabletSCD84ee5fbf-7299-4b8a-e053-2a91aa0aa1593

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-4816-36807148160330 TABLET, FILM COATED in 1 BOTTLE (68071-4816-3) 2026-02-25NoNoCurrent
68071-4816-868071481608180 TABLET, FILM COATED in 1 BOTTLE (68071-4816-8) 2019-03-25NoNoCurrent