olanzapine

Generic: olanzapine

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

olanzapine 10 mg/2mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9199
Product ID 0143-9199_0143693c-5d42-4674-9b76-06e8e9e0ed63
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218116
Listing Expiration 2026-12-31
Marketing Start 2025-09-18

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439199
Hyphenated Format 0143-9199

Supplemental Identifiers

RxCUI
485968
UPC
0301439199014
UNII
N7U69T4SZR
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 (source: ndc)
Generic Name olanzapine (source: ndc)
Application Number ANDA218116 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 10 mg/2mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (0143-9199-01) / 2 mL in 1 VIAL
source: ndc

Packages (1)

0143-9199-01 1 VIAL in 1 CARTON (0143-9199-01) / 2 mL in 1 VIAL

Ingredients (1)

olanzapine (10 mg/2mL)

Linked Drug Pages (1)

Olanzapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "0143693c-5d42-4674-9b76-06e8e9e0ed63", "openfda": {"nui": ["N0000175430"], "upc": ["0301439199014"], "unii": ["N7U69T4SZR"], "rxcui": ["485968"], "spl_set_id": ["63bcfe98-d1fc-4cd7-9212-f59ee4dcc6d1"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0143-9199-01)  / 2 mL in 1 VIAL", "package_ndc": "0143-9199-01", "marketing_start_date": "20250918"}], "brand_name": "Olanzapine", "product_id": "0143-9199_0143693c-5d42-4674-9b76-06e8e9e0ed63", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0143-9199", "generic_name": "Olanzapine", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/2mL"}], "application_number": "ANDA218116", "marketing_category": "ANDA", "marketing_start_date": "20250918", "listing_expiration_date": "20261231"}