Basic Information
Carvedilol Phosphate
63629-9635
Regulatory Information
63629-9635
ANDA090132
C73584
February 19, 2021
USA
These highlights do not include all the information needed to use CARVEDILOL PHOSPHATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for CARVEDILOL PHOSPHATE EXTENDED-RELEASE CAPSULES. CARVEDILOL PHOSPHATE extended-release capsules, for oral use Initial U.S. Approval: 1995
HUMAN PRESCRIPTION DRUG LABEL
100
Company Information
171714327
Active Ingredients
CROSPOVIDONE (120 .MU.M)
Code: 68401960MK
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
Code: NX76LV5T8J
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)
Code: 74G4R6TH13
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
TRIETHYL CITRATE
Code: 8Z96QXD6UM
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
ALUMINUM OXIDE
Code: LMI26O6933
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
Active Moieties
CARVEDILOL
Code: 0K47UL67F2