Carvedilol Phosphate

Product NDC
67046-1551
11-digit product format
670461551
Labeler code
67046
Product ID
67046-1551_325da392-3ebb-37a2-e063-6394a90ad39d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA090132
Marketing category
ANDA
Marketing start
2025-04-09
Substance
CARVEDILOL PHOSPHATE
Active strength
10 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 PHOSPHATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEQT531S367
Rxcui860510

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
67046-1551-3Carvedilol Phosphate30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1551CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [COUPLER LLC]1Current NDC, 1 package rows20250410_325dae60-01ce-a120-e063-6294a90a2ef2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSN325dae60-01ce-a120-e063-6294a90a2ef21
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCD325dae60-01ce-a120-e063-6294a90a2ef21
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSY325dae60-01ce-a120-e063-6294a90a2ef21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1551-36704615510330 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1551-3) 2025-04-09NoNoHistorical