Carvedilol

Product NDC
63187-409
11-digit product format
631870409
Labeler code
63187
Product ID
63187-409_c48346c2-771d-4929-800c-1066f2def5dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078332
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
2026-12-31
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
A078332-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A078332-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A078332-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A078332-004CARVEDILOLCARVEDILOL25MGTABLET / 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
A078332-001AB
A078332-002AB
A078332-003AB
A078332-004AB

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 06:07:402026-07A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-004CARVEDILOL25MGTABLET / ORALAB2007-09-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-004CARVEDILOL25MGTABLET / 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 06:07:402026-07A078332-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A078332-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078332-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078332-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078332-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078332-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078332-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078332-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078332-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078332-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078332-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078332-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078332-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200032Internal RxNorm lookup
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
cd7e7c34-6958-47be-a1c1-f1ed948e2687Available 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
63187-409-30Carvedilol30 in 1 BOTTLETABLET, FILM COATED305
63187-409-60Carvedilol60 in 1 BOTTLETABLET, FILM COATED605
63187-409-90Carvedilol90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-409-30EA - Each63187-4095703c821-b4c2-4b1e-8251-81d68b509f4d12017-11-06
63187-409-60EA - Each63187-4093b31f279-6689-4b54-be02-4b7730f9cad312017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARVEDILOLACTIVE INGREDIENT0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CARVEDILOLACTIVE MOIETY0K47UL67F2CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-409CARVEDILOL TABLET, FILM COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220722_cd7e7c34-6958-47be-a1c1-f1ed948e2687.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
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.0930965b-80e3-4a0c-bffc-14ac32a478942025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.2be8635b-5733-1ed4-e054-00144ff88e882025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.8640adde-d071-44a4-97d0-fa8a8548debe2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLPD-Rx Pharmaceuticals, Inc.205da5d0-05d9-440d-bb5a-b30b826900ab2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLA-S Medication Solutionsf5969d18-46c7-4f35-9668-2fd4f6bbeb172025-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLBryant Ranch Prepackfe4aa7f0-6ef2-4a95-8a64-5e3365f104742024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLNuCare Pharmaceuticals,Inc.786e8ad3-a8d7-41e6-e053-2991aa0a32c72024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLAurobindo Pharma Limited7cc14b86-0833-4c3c-91f3-7963d7052fd52024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LPcd7e7c34-6958-47be-a1c1-f1ed948e26872022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
ndc (product): 63187-409
CarvedilolCARVEDILOLProficient Rx LP36230cc8-e808-4f74-a27d-4367eecd21f72022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLProficient Rx LP55a19ff1-f8c1-4cf0-8711-9bfa32756de92020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332
CarvedilolCARVEDILOLAphena Pharma Solutions - Tennessee, LLCd0089df4-37c8-41de-810c-14c9dc06f0c32018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078332
application number: ANDA078332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200032carvedilol 12.5 MG Oral TabletPSNcd7e7c34-6958-47be-a1c1-f1ed948e26875
200033carvedilol 25 MG Oral TabletPSNcd7e7c34-6958-47be-a1c1-f1ed948e26875
200032carvedilol 12.5 MG Oral TabletSCDcd7e7c34-6958-47be-a1c1-f1ed948e26875
200033carvedilol 25 MG Oral TabletSCDcd7e7c34-6958-47be-a1c1-f1ed948e26875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-409-306318704093030 TABLET, FILM COATED in 1 BOTTLE (63187-409-30) 2018-12-010000-00-00NoNoCurrent
63187-409-606318704096060 TABLET, FILM COATED in 1 BOTTLE (63187-409-60) 2018-12-010000-00-00NoNoCurrent
63187-409-906318704099090 TABLET, FILM COATED in 1 BOTTLE (63187-409-90) 2018-12-010000-00-00NoNoCurrent