olanzapine

Generic: olanzapine

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

olanzapine 10 mg/2mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-1800
Product ID 39822-1800_3aad1759-6c3d-9723-e063-6294a90a1d18
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211072
Listing Expiration 2026-12-31
Marketing Start 2025-08-28

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398221800
Hyphenated Format 39822-1800

Supplemental Identifiers

RxCUI
485968
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 ANDA211072 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 10 mg/2mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (39822-1800-1) / 2 mL in 1 VIAL
source: ndc

Packages (1)

39822-1800-1 1 VIAL in 1 CARTON (39822-1800-1) / 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": "3aad1759-6c3d-9723-e063-6294a90a1d18", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["485968"], "spl_set_id": ["3aad0f7b-8d0c-a9bf-e063-6394a90a6ae8"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (39822-1800-1)  / 2 mL in 1 VIAL", "package_ndc": "39822-1800-1", "marketing_start_date": "20250902"}], "brand_name": "Olanzapine", "product_id": "39822-1800_3aad1759-6c3d-9723-e063-6294a90a1d18", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "39822-1800", "generic_name": "Olanzapine", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/2mL"}], "application_number": "ANDA211072", "marketing_category": "ANDA", "marketing_start_date": "20250828", "listing_expiration_date": "20261231"}