NDC Code(s) : 72162-2037-3
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

RisperidoneRisperidone SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72162-2037(NDC:27808-002)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RISPERIDONE(UNII: L6UH7ZF8HC)
(RISPERIDONE - UNII:L6UH7ZF8HC) 		RISPERIDONE1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZOIC ACID(UNII: 8SKN0B0MIM)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SORBITOL SOLUTION(UNII: 8KW3E207O2)
TARTARIC ACID(UNII: W4888I119H)
WATER(UNII: 059QF0KO0R)
Product Characteristics
Color white (colorless) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72162-2037-330 mL in 1 BOTTLE Type 0: Not a Combination Product06/06/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079059 03/13/2015

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(72162-2037), RELABEL(72162-2037)

PRINCIPAL DISPLAY PANEL

Risperidone 1 mg/ml Solution #30

Label