NDC Code(s) : 67877-457-47
Packager : Ascend Laboratories, LLC

Category : Human Prescription Drug Label

DEA Schedule : CV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pregabalin Pregabalin SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:67877-457
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN(UNII: 55JG375S6M)
(PREGABALIN - UNII:55JG375S6M) 		PREGABALIN20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(UNII: 22ADO53M6F)
WATER(UNII: 059QF0KO0R)
CHERRY(UNII: BUC5I9595W)
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67877-457-47473 mL in 1 BOTTLE Type 0: Not a Combination Product21/07/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207623 07/21/2019

LABELER - Ascend Laboratories, LLC(141250469)

Establishment
Name Address ID/FEI Business Operations
Alkem Laboratories Limited 915628612 MANUFACTURE(67877-457)

PRINCIPAL DISPLAY PANEL

NDC 67877-457-47
Pregabalin Oral Solution
20 mg/ml
Rx Only
16 fl oz (473 ml)
 pregabalin-container-label
NDC 67877-457-47
Pregabalin Oral Solution
20 mg/ml
Rx Only
16 fl oz (473 ml) (Carton label)

 pregabalin-container-label