FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
51407-053
11-digit product format
514070053
Labeler code
51407
Product ID
51407-053_47c099ed-1220-236c-e063-6294a90a968e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA090132
Marketing category
ANDA
Marketing start
2017-10-25
Substance
CARVEDILOL PHOSPHATE
Active strength
80 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

Additional Listing Data#

Finished product
Yes
Brand name base
Carvedilol Phosphate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARVEDILOL PHOSPHATE80 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
51407-053-30Carvedilol Phosphate30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-053-30EA - Each51407-05380288547-b21c-4410-acf2-e4b676d37c4a12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-053CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [GOLDEN STATE MEDICAL SUPPLY, INC.]8Current NDC, Legacy NDC, 1 package rows20241019_669ec7f8-f27d-4048-a784-00ca903cc658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
51407-053-305140700533030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-053-30) 2018-02-160000-00-00NoNoCurrent