Carvedilol

Product NDC
50090-4171
Requested package NDC
50090-4171-3
11-digit product format
500904171
Labeler code
50090
Product ID
50090-4171_fc284893-e0aa-4d94-bb4e-3d994e519613
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077614
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

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
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 · 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 UTC2026-02A077614-001CARVEDILOL6.25MGTABLET / 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…
2024-10-29 15:01 UTC2024-10A077614-001CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077614-002CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077614-003CARVEDILOL25MGTABLET / ORALAB2007-09-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A077614-004CARVEDILOL3.125MGTABLET / 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 UTC2026-02A077614-001AB1011fe1cb6892…
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…
2024-10-29 15:01 UTC2024-10A077614-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077614-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077614-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077614-004AB1d06236e962d9…

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
dd8b2a3f-c2fa-4859-84a1-c02f2b608748Available 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#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4171-02023-02-07These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
50090-4171-12023-02-07These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
50090-4171-32023-02-07These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
50090-4171-42023-02-07These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
50090-4171-02023-01-30These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
50090-4171-12023-01-30These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
50090-4171-32023-01-30These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995
50090-4171-42023-01-30These highlights do not include all the information needed to use CARVEDILOL TABLETS safely and effectively. See full prescribing information for CARVEDILOL TABLETS. CARVEDILOL tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4171-0Carvedilol60 in 1 BOTTLETABLET, FILM COATED609
50090-4171-1Carvedilol180 in 1 BOTTLETABLET, FILM COATED1809
50090-4171-3Carvedilol90 in 1 BOTTLETABLET, FILM COATED909
50090-4171-4Carvedilol30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4171-0EA - Each50090-417166b410f0-a96a-44c7-a518-6da67736739a12024-12-10
50090-4171-1EA - Each50090-41719c5b9b55-d3a8-473d-990d-432f040becea12024-12-10
50090-4171-3EA - Each50090-4171038d7c50-e89c-4fd7-8d64-71bd011cffb212024-12-10
50090-4171-4EA - Each50090-4171d24553ae-eeeb-4de9-afb7-3ef137aa1c3e12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4171CARVEDILOL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 4 package rows20241115_dd8b2a3f-c2fa-4859-84a1-c02f2b608748.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 · 45 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
CarvedilolCARVEDILOLA-S Medication Solutionsadd1ee3d-fca4-4301-b871-7dda6eda7bb72026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077614
application number: ANDA077614

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200033carvedilol 25 MG Oral TabletPSNdd8b2a3f-c2fa-4859-84a1-c02f2b6087489
200033carvedilol 25 MG Oral TabletSCDdd8b2a3f-c2fa-4859-84a1-c02f2b6087489

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4171-35009041710390 TABLET, FILM COATED in 1 BOTTLE (50090-4171-3) 2021-09-240000-00-00NoNoCurrent