NDC Code(s) : 55700-927-30
Packager : Quality Care Products, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OlanzapineOlanzapine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-927(NDC:43598-166)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
olanzapine(UNII: N7U69T4SZR)
(OLANZAPINE - UNII:N7U69T4SZR) 		olanzapine10 mg
Inactive Ingredients
Ingredient Name Strength
Crospovidone(UNII: 2S7830E561)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
lactose monohydrate(UNII: EWQ57Q8I5X)
magnesium stearate(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
hypromelloses(UNII: 3NXW29V3WO)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
titanium dioxide(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 10 mm
Flavor Imprint Code R10;0166
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-927-3030 in 1 BOTTLE Type 0: Not a Combination Product27/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076255 08/27/2021

LABELER - Quality Care Products, LLC(831276758)

Establishment
Name Address ID/FEI Business Operations
Quality Care Products, LLC 831276758 repack(55700-927)

PRINCIPAL DISPLAY PANEL

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