FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
71335-0308
11-digit product format
713350308
Labeler code
71335
Product ID
71335-0308_b6c426df-a1bd-4236-a74a-0f990b07338f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carvedilol Phosphate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090132
Marketing category
ANDA
Marketing start
2017-11-08
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
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 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
71335-0308-1Carvedilol Phosphate30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE30103
71335-0308-2Carvedilol Phosphate90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE90103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0308-1EA - Each71335-0308d3ca525a-f4de-4186-a6fb-f290e2d8696f12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0308CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240509_3697789e-ed17-4433-af94-e8ea19d8e04d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860510carvedilol phosphate 10 MG 24HR Extended Release Oral CapsulePSN3697789e-ed17-4433-af94-e8ea19d8e04d103
86051024 HR carvedilol phosphate 10 MG Extended Release Oral CapsuleSCD3697789e-ed17-4433-af94-e8ea19d8e04d103
860510carvedilol phosphate 10 MG 24 HR Extended Release Oral CapsuleSY3697789e-ed17-4433-af94-e8ea19d8e04d103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-0308-17133503080130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-0308-1) 2023-09-22NoNoHistorical
71335-0308-27133503080290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71335-0308-2) 2023-09-22NoNoHistorical