olanzapine and fluoxetine (0093-5503)

Drug Facts

Product Profile

Brand Name olanzapine and fluoxetine

Generic Name olanzapine and fluoxetine

Labeler teva pharmaceuticals usa, inc.

Dosage Form CAPSULE

Routes

ORAL

Active Ingredients

fluoxetine hydrochloride 25 mg/1, olanzapine 3 mg/1

Manufacturer

Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5503

Product ID 0093-5503_49dfc18c-9d68-4489-83f5-d59bb2596b80

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202074

Listing Expiration 2026-12-31

Marketing Start 2013-04-10

Pharmacologic Class

Established (EPC)

atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00935503

Hyphenated Format 0093-5503

Supplemental Identifiers

RxCUI

403969 403970 403971 403972 721787

UPC

0300935506562 0300935503561 0300935505565 0300935507569 0300935504568

UNII

N7U69T4SZR I9W7N6B1KJ

NUI

N0000175430

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olanzapine and fluoxetine (source: ndc)

Generic Name olanzapine and fluoxetine (source: ndc)

Application Number ANDA202074 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
3 mg/1

source: ndc

Packaging

30 CAPSULE in 1 BOTTLE (0093-5503-56)

source: ndc

Packages (1)

0093-5503-56 30 CAPSULE in 1 BOTTLE (0093-5503-56)

Ingredients (2)

fluoxetine hydrochloride (25 mg/1) olanzapine (3 mg/1)

Linked Drug Pages (1)

Olanzapine and Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "49dfc18c-9d68-4489-83f5-d59bb2596b80", "openfda": {"nui": ["N0000175430"], "upc": ["0300935506562", "0300935503561", "0300935505565", "0300935507569", "0300935504568"], "unii": ["N7U69T4SZR", "I9W7N6B1KJ"], "rxcui": ["403969", "403970", "403971", "403972", "721787"], "spl_set_id": ["3c28cf18-01a3-468a-ab3e-8aa82f918251"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (0093-5503-56)", "package_ndc": "0093-5503-56", "marketing_start_date": "20130410"}], "brand_name": "Olanzapine and Fluoxetine", "product_id": "0093-5503_49dfc18c-9d68-4489-83f5-d59bb2596b80", "dosage_form": "CAPSULE", "pharm_class": ["Atypical Antipsychotic [EPC]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "0093-5503", "generic_name": "Olanzapine and Fluoxetine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine and Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "OLANZAPINE", "strength": "3 mg/1"}], "application_number": "ANDA202074", "marketing_category": "ANDA", "marketing_start_date": "20130410", "listing_expiration_date": "20261231"}