NDC Code(s) : 70518-1826-0, 70518-1826-1, 70518-1826-2
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CarvedilolCarvedilol TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-1826(NDC:68382-095)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARVEDILOL(UNII: 0K47UL67F2)
(CARVEDILOL - UNII:0K47UL67F2) 		CARVEDILOL25 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CROSPOVIDONE (12 MPA.S AT 5%)(UNII: 40UAA97IT9)
Product Characteristics
Color white (WHITE TO OFF-WHITE) Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code ZC42
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70518-1826-030 in 1 BLISTER PACK Type 0: Not a Combination Product26/01/2019
2NDC:70518-1826-1180 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product13/03/2019
3NDC:70518-1826-290 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product26/04/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077614 01/26/2019

LABELER - REMEDYREPACK INC.(829572556)

PRINCIPAL DISPLAY PANEL

DRUG: Carvedilol

GENERIC: Carvedilol

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-1826-0

NDC: 70518-1826-1

NDC: 70518-1826-2

COLOR: white

SHAPE: ROUND

SCORE: No score

SIZE: 10 mm

IMPRINT: ZC42

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 180 in 1 BOTTLE PLASTIC

PACKAGING: 90 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • CARVEDILOL 25mg in 1

INACTIVE INGREDIENT(S):

  • HYPROMELLOSE, UNSPECIFIED
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • SILICON DIOXIDE
  • POVIDONE K30
  • TALC
  • TITANIUM DIOXIDE
  • CROSPOVIDONE (12 MPA.S AT 5%)

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/xml/0e98593a-8424-48c8-acc0-671f4b566aee/Remedy_Label.jpg

/xml/0e98593a-8424-48c8-acc0-671f4b566aee/Remedy_Label.jpg