FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
57664-665
11-digit product format
576640665
Labeler code
57664
Product ID
57664-665_468e6649-e69b-4938-e063-6394a90ad7a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090132
Marketing category
ANDA
Marketing start
2017-11-08
Substance
CARVEDILOL PHOSPHATE
Active strength
40 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL PHOSPHATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEQT531S367
Rxcui860510, 860516, 860522, 860532

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
57664-665-83Carvedilol Phosphate30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-665-83EA - Each57664-66540c90efd-0904-49ad-afbd-266fbbed602412017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-665CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]14Current NDC, Legacy NDC, 1 package rows20240308_a9314bc0-fd5d-477b-bef5-3bee532774c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSNcea10014-72b0-4190-a391-733c8912efe0102
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCDcea10014-72b0-4190-a391-733c8912efe0102
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSYcea10014-72b0-4190-a391-733c8912efe0102
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSNa9314bc0-fd5d-477b-bef5-3bee532774c017
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSNa9314bc0-fd5d-477b-bef5-3bee532774c017
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSNa9314bc0-fd5d-477b-bef5-3bee532774c017
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSNa9314bc0-fd5d-477b-bef5-3bee532774c017
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCDa9314bc0-fd5d-477b-bef5-3bee532774c017
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCDa9314bc0-fd5d-477b-bef5-3bee532774c017
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCDa9314bc0-fd5d-477b-bef5-3bee532774c017
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCDa9314bc0-fd5d-477b-bef5-3bee532774c017
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSYa9314bc0-fd5d-477b-bef5-3bee532774c017
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSYa9314bc0-fd5d-477b-bef5-3bee532774c017
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSYa9314bc0-fd5d-477b-bef5-3bee532774c017
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSYa9314bc0-fd5d-477b-bef5-3bee532774c017
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSN669ec7f8-f27d-4048-a784-00ca903cc65810
860516carvedilol phosphate 20 MG 24HR Extended Release Oral CapsulePSN669ec7f8-f27d-4048-a784-00ca903cc65810
860522carvedilol phosphate 40 MG 24HR Extended Release Oral CapsulePSN669ec7f8-f27d-4048-a784-00ca903cc65810
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSN669ec7f8-f27d-4048-a784-00ca903cc65810
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCD669ec7f8-f27d-4048-a784-00ca903cc65810
86051624 HR carvedilol phosphate 20 MG Extended Release Oral CapsuleSCD669ec7f8-f27d-4048-a784-00ca903cc65810
86052224 HR carvedilol phosphate 40 MG Extended Release Oral CapsuleSCD669ec7f8-f27d-4048-a784-00ca903cc65810
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCD669ec7f8-f27d-4048-a784-00ca903cc65810
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSY669ec7f8-f27d-4048-a784-00ca903cc65810
860516carvedilol phosphate 20 MG 24 HR Extended Release Oral CapsuleSY669ec7f8-f27d-4048-a784-00ca903cc65810
860522carvedilol phosphate 40 MG 24 HR Extended Release Oral CapsuleSY669ec7f8-f27d-4048-a784-00ca903cc65810
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSY669ec7f8-f27d-4048-a784-00ca903cc65810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57664-665-835766406658330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (57664-665-83) 2017-11-080000-00-00NoNoCurrent