Carvedilol

Product NDC
50090-4898
11-digit product format
500904898
Labeler code
50090
Product ID
50090-4898_b7432b96-4546-4a59-9ed1-9ba146d4b40a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078251
Marketing category
ANDA
Marketing start
2007-09-05
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

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4898-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4898-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4898-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4898-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4898-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4898-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4898-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4898-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4898-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4898-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4898-0367a005e9d99…383a685ebd0f…

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
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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078251-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078251-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078251-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078251-004CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
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…

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 06:07:402026-07A078251-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078251-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078251-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078251-004AB1caaa826d4ba7…
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…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200033Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c8d54e6-835c-4fa7-b13b-b798916cfed3Available 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
50090-4898-0Carvedilol90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4898-0EA - Each50090-48982d46d0e0-c969-41ce-88fd-7cc0123718a312026-02-05

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
CarvedilolCARVEDILOLRedpharm Drug58337744-a130-35ef-e063-6294a90a080b2026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078251
application number: ANDA078251
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
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
ndc (product): 50090-4898
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
200033carvedilol 25 MG Oral TabletPSN3c8d54e6-835c-4fa7-b13b-b798916cfed36
200033carvedilol 25 MG Oral TabletSCD3c8d54e6-835c-4fa7-b13b-b798916cfed36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4898-05009048980090 TABLET, FILM COATED in 1 BOTTLE (50090-4898-0) 2020-02-140000-00-00NoNoCurrent