Olanzapine and Fluoxetine: Package Insert and Label Information (Page 13 of 13)

PRINCIPAL DISPLAY PANEL – 3mg/25mg — 30 CAPSULES

3mg/25mg label
(click image for full-size original)
3mg/25mg label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 6mg/25mg — 30 CAPSULES

6mg/25mg -- 30 capsules
(click image for full-size original)
6mg/25mg -- 30 capsules
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 6mg/50mg — 30 CAPSULES

6mg/50mg -- 30 capsules
(click image for full-size original)
6mg/50mg -- 30 capsules
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 12mg/25mg — 30 CAPSULES

12mg/25mg -- 30 capsules
(click image for full-size original)
12mg/25mg -- 30 capsules
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – 12mg/50mg — 30 CAPSULES

12mg/50mg label
(click image for full-size original)
12mg/50mg label
(click image for full-size original)
OLANZAPINE AND FLUOXETINE olanzapine and fuoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-277
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 3 mg
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
MAGNESIUM STEARATE
TITANIUM DIOXIDE
METHYL ALCOHOL
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
STARCH, CORN
ALCOHOL
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color white (white opaque body) , orange (orange opaque cap) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 277;par
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-277-11 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077742 11/26/2012
OLANZAPINE AND FLUOXETINE olanzapine and fuoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-250
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 6 mg
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
ALCOHOL
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
METHYL ALCOHOL
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color yellow (rich yellow opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 250;par
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-250-11 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077742 11/26/2012
OLANZAPINE AND FLUOXETINE olanzapine and fuoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-251
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 6 mg
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 50 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
METHYL ALCOHOL
ALCOHOL
PROPYLENE GLYCOL
SHELLAC
FD&C RED NO. 3
FD&C YELLOW NO. 6
Product Characteristics
Color yellow (rich yellow opaque cap) , gray (light grey opaque body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 251;par
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-251-11 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077742 11/26/2012
OLANZAPINE AND FLUOXETINE olanzapine and fuoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-252
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 12 mg
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 25 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
METHYL ALCOHOL
ALCOHOL
PROPYLENE GLYCOL
SHELLAC
D&C RED NO. 28
FERRIC OXIDE RED
Product Characteristics
Color brown (dark tan opaque body) , red (red opaque cap) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 252;par
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-252-11 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077742 11/26/2012
OLANZAPINE AND FLUOXETINE olanzapine and fuoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-253
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLANZAPINE (OLANZAPINE) OLANZAPINE 12 mg
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 50 mg
Inactive Ingredients
Ingredient Name Strength
GELATIN
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
FERROSOFERRIC OXIDE
METHYL ALCOHOL
ALCOHOL
PROPYLENE GLYCOL
SHELLAC
D&C RED NO. 28
FD&C RED NO. 3
FD&C YELLOW NO. 6
Product Characteristics
Color gray (light grey opaque body) , red (red opaque cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 253;par
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-253-11 30 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077742 11/26/2012
Labeler — Par Pharmaceutical, Inc. (092733690)

Revised: 07/2022 Par Pharmaceutical, Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

https://druginserts.com/lib/rx/meds/olanzapine-and-fluoxetine/page/13/

Clinical Trials

DrugInserts.com

Information Sections

RSS Feeds

About

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.