FDA.reportPublic FDA data

Carvedilol Phosphate

Product NDC
63629-9635
11-digit product format
636299635
Labeler code
63629
Product ID
63629-9635_52a48710-e1dc-4d44-9e99-61c6e003023a
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
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
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 PHOSPHATE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEQT531S367
Rxcui860532

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
63629-9635-1Carvedilol Phosphate30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE30102
63629-9635-2Carvedilol Phosphate90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE90102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9635-1EA - Each63629-96354ecb48a2-47ac-4c31-ae9c-bdd0981d59cd12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9635CARVEDILOL PHOSPHATE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20240509_c462ce0b-486d-4599-ba60-b836781779d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860532carvedilol phosphate 80 MG 24HR Extended Release Oral CapsulePSNc462ce0b-486d-4599-ba60-b836781779d3102
86053224 HR carvedilol phosphate 80 MG Extended Release Oral CapsuleSCDc462ce0b-486d-4599-ba60-b836781779d3102
860532carvedilol phosphate 80 MG 24 HR Extended Release Oral CapsuleSYc462ce0b-486d-4599-ba60-b836781779d3102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-9635-16362996350130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9635-1) 2023-05-11NoNoCurrent
63629-9635-26362996350290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9635-2) 2023-05-11NoNoCurrent