FDA.reportPublic FDA data

Olanzapine and Fluoxetine

Product NDC
49884-253
11-digit product format
498840253
Labeler code
49884
Product ID
49884-253_d4b26d87-0345-449f-88c1-2d6a9eefd699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olanzapine and fuoxetine
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA077742
Marketing category
ANDA
Marketing start
2012-11-26
Substance
FLUOXETINE HYDROCHLORIDE; OLANZAPINE
Active strength
50; 12 mg/1; mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine and Fluoxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE50 mg/1
OLANZAPINE12 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR, I9W7N6B1KJ
Rxcui403969, 403970, 403971, 403972, 721787

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9Product name620250331
e5b459e3-ddce-4802-aab4-2c901d71ae85Product name520250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464Product name320240130
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-253-11Olanzapine and Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE3022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-253-11EA - Each49884-253862f5dea-b3a9-4c29-a025-5ffbd730259a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOXETINE HYDROCHLORIDEACTIVE INGREDIENTI9W7N6B1KJOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
OLANZAPINEACTIVE INGREDIENTN7U69T4SZROLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FLUOXETINEACTIVE MOIETY01K63SUP8DOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
OLANZAPINEACTIVE MOIETYN7U69T4SZROLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
GELATININACTIVE INGREDIENT2G86QN327LOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
METHYL ALCOHOLINACTIVE INGREDIENTY4S76JWI15OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
SHELLACINACTIVE INGREDIENT46N107B71OOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [PAR PHARMACEUTICAL, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-253OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE) CAPSULE [ENDO USA, INC.]15Current NDC, Legacy NDC, 1 package rows20241215_2f6ceda3-3edc-4427-98a6-23e3c930c44d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
403970OLANZapine 12 MG / FLUoxetine HCl 25 MG Oral CapsulePSN2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403971OLANZapine 12 MG / FLUoxetine HCl 50 MG Oral CapsulePSN2f6ceda3-3edc-4427-98a6-23e3c930c44d22
721787OLANZapine 3 MG / FLUoxetine HCl 25 MG Oral CapsulePSN2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403969OLANZapine 6 MG / FLUoxetine HCl 25 MG Oral CapsulePSN2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403972OLANZapine 6 MG / FLUoxetine HCl 50 MG Oral CapsulePSN2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403970fluoxetine 25 MG / olanzapine 12 MG Oral CapsuleSCD2f6ceda3-3edc-4427-98a6-23e3c930c44d22
721787fluoxetine 25 MG / olanzapine 3 MG Oral CapsuleSCD2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403969fluoxetine 25 MG / olanzapine 6 MG Oral CapsuleSCD2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403971fluoxetine 50 MG / olanzapine 12 MG Oral CapsuleSCD2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403972fluoxetine 50 MG / olanzapine 6 MG Oral CapsuleSCD2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403970fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral CapsuleSY2f6ceda3-3edc-4427-98a6-23e3c930c44d22
721787fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 3 MG Oral CapsuleSY2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403969fluoxetine 25 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral CapsuleSY2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403971fluoxetine 50 MG (as fluoxetine hydrochloride) / olanzapine 12 MG Oral CapsuleSY2f6ceda3-3edc-4427-98a6-23e3c930c44d22
403972fluoxetine 50 MG (as fluoxetine hydrochloride) / olanzapine 6 MG Oral CapsuleSY2f6ceda3-3edc-4427-98a6-23e3c930c44d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-253-114988402531130 CAPSULE in 1 BOTTLE, PLASTIC (49884-253-11) 30 capsule2012-11-260000-00-00NoNoCurrent