NDC Code(s) : 71335-0714-5, 71335-0714-1, 71335-0714-2, 71335-0714-3, 71335-0714-4
Packager : Bryant Ranch Prepack

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:71335-0714(NDC:43598-164)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE(UNII: N7U69T4SZR)
(OLANZAPINE - UNII:N7U69T4SZR) 		OLANZAPINE5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
HYDROXYPROPYL CELLULOSE (110000 WAMW)(UNII: 5Y0974F5PW)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
HYPROMELLOSE, UNSPECIFIED(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 8 mm
Flavor Imprint Code R5;0164
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71335-0714-5120 in 1 BOTTLE Type 0: Not a Combination Product27/12/2021
2NDC:71335-0714-130 in 1 BOTTLE Type 0: Not a Combination Product03/02/2018
3NDC:71335-0714-215 in 1 BOTTLE Type 0: Not a Combination Product27/12/2021
4NDC:71335-0714-360 in 1 BOTTLE Type 0: Not a Combination Product27/12/2021
5NDC:71335-0714-490 in 1 BOTTLE Type 0: Not a Combination Product27/12/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076255 12/10/2013

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-0714), RELABEL(71335-0714)

PRINCIPAL DISPLAY PANEL

Olanzapine 5mg Tablet

Label