olanzapine

Generic: olanzapine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6376
Product ID 0904-6376_efc47d5e-306c-464d-92a4-5156031202cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076255
Listing Expiration 2026-12-31
Marketing Start 2012-04-23

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046376
Hyphenated Format 0904-6376

Supplemental Identifiers

RxCUI
312078 314154
UNII
N7U69T4SZR
NUI
N0000175430

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 (source: ndc)
Generic Name olanzapine (source: ndc)
Application Number ANDA076255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-6376-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6376-61 100 BLISTER PACK in 1 CARTON (0904-6376-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

olanzapine (10 mg/1)

Linked Drug Pages (1)

Olanzapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "efc47d5e-306c-464d-92a4-5156031202cf", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312078", "314154"], "spl_set_id": ["0ecbf540-572e-4ca4-b694-18ca1cd1c194"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6376-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6376-61", "marketing_start_date": "20120423"}], "brand_name": "Olanzapine", "product_id": "0904-6376_efc47d5e-306c-464d-92a4-5156031202cf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0904-6376", "generic_name": "Olanzapine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/1"}], "application_number": "ANDA076255", "marketing_category": "ANDA", "marketing_start_date": "20120423", "listing_expiration_date": "20261231"}