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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
EQT531S367CARVEDILOL PHOSPHATE610309-89-2CARVEDILOL PHOSPHATE

Packages

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

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Carvedilol PhosphateBryant Ranch Prepack2025-07-14HUMAN PRESCRIPTION DRUG LABEL102