FDA.reportPublic FDA data

CARVEDILOL

Product NDC
72789-431
Requested package NDC
72789-431-60
11-digit product format
727890431
Labeler code
72789
Product ID
72789-431_4bc0f6dd-34be-c7d8-e063-6294a90ad065
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CARVEDILOL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078165
Marketing category
ANDA
Marketing start
2021-07-29
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

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
A078165-001CARVEDILOLCARVEDILOL3.125MGTABLET / ORALAB2007-09-05
A078165-002CARVEDILOLCARVEDILOL6.25MGTABLET / ORALAB2007-09-05
A078165-003CARVEDILOLCARVEDILOL12.5MGTABLET / ORALAB2007-09-05
A078165-004CARVEDILOLCARVEDILOL25MGTABLET / 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
A078165-001AB
A078165-002AB
A078165-003AB
A078165-004AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078165-001CARVEDILOL3.125MGTABLET / ORALAB2007-09-05a50c72e98297…
2026-08-01 22:54:322026-06A078165-002CARVEDILOL6.25MGTABLET / ORALAB2007-09-05a50c72e98297…
2026-08-01 22:54:322026-06A078165-003CARVEDILOL12.5MGTABLET / ORALAB2007-09-05a50c72e98297…
2026-08-01 22:54:322026-06A078165-004CARVEDILOL25MGTABLET / ORALAB2007-09-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078165-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A078165-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A078165-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A078165-004AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CARVEDILOLCARVEDILOLPD-Rx Pharmaceuticals, Inc.95300809-be15-461e-904e-b56aba6769752026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
ndc (package): 72789-431-60
ndc (product): 72789-431
ndc11 (package): 72789043160
CARVEDILOLCARVEDILOLPD-Rx Pharmaceuticals, Inc.9959f5d7-c363-4b8d-b8b9-7b45a8cb9aa92026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLNuCare Pharmaceuticals, Inc.574c419f-3b9e-2171-e063-6394a90a0e902026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLBryant Ranch Prepack03b7c07c-14ba-40c8-8c0a-8dfa4a10f5802026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLBryant Ranch Prepackfe462198-32ae-4f6c-befc-acb97fb017c92026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLBryant Ranch Prepack1ddff189-1848-4186-bca9-063e4ea7fd1f2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLNuCare Pharmaceuticals, Inc.4bbf3767-8666-22d8-e063-6294a90a2afe2026-02-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLAdvagen Pharma Ltd7a7d3ca1-05b0-4c7e-aefa-492cc441585d2026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLA-S Medication Solutions5eeeaeee-9698-493f-9aa7-d130681472082026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLA-S Medication Solutions947baca7-f9c8-4821-b47b-53c45288613e2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLPreferred Pharmaceuticals Inc.8d3937b4-e0dd-4165-9825-bbf5020d79f92025-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLRedPharm Drug, Incfcb1de7c-1878-1835-e053-6294a90abe952025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165
CARVEDILOLCARVEDILOLRedPharm Drug, Incfcb2025f-11a1-ea73-e053-6394a90a61cb2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078165
application number: ANDA078165

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
95300809-be15-461e-904e-b56aba676975Available 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
72789-431-60CARVEDILOL60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-431-60EA - Each72789-431299534b8-4d71-4798-9dd4-de57917b46a512024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-431CARVEDILOL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20240921_95300809-be15-461e-904e-b56aba676975.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200031carvedilol 6.25 MG Oral TabletPSN95300809-be15-461e-904e-b56aba6769754
200031carvedilol 6.25 MG Oral TabletSCD95300809-be15-461e-904e-b56aba6769754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-431-607278904316060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-431-60) 2024-09-19NoNoCurrent