olanzapine intramuscular

Generic: olanzapine

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine intramuscular
Generic Name olanzapine
Labeler pai holdings, llc dba pai pharma
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

olanzapine 10 mg/2mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1072
Product ID 0121-1072_1e5f9343-d43d-4ff7-b1ae-b6358640bbba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211072
Listing Expiration 2026-12-31
Marketing Start 2025-07-25

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211072
Hyphenated Format 0121-1072

Supplemental Identifiers

RxCUI
485968
UPC
0301211072559
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 intramuscular (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 (0121-1072-55) / 2 mL in 1 VIAL
source: ndc

Packages (1)

0121-1072-55 1 VIAL in 1 CARTON (0121-1072-55) / 2 mL in 1 VIAL

Ingredients (1)

olanzapine (10 mg/2mL)

Linked Drug Pages (1)

Olanzapine Intramuscular ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "1e5f9343-d43d-4ff7-b1ae-b6358640bbba", "openfda": {"nui": ["N0000175430"], "upc": ["0301211072559"], "unii": ["N7U69T4SZR"], "rxcui": ["485968"], "spl_set_id": ["9d9f25d5-4513-434a-a37a-392a0c978f2e"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (0121-1072-55)  / 2 mL in 1 VIAL", "package_ndc": "0121-1072-55", "marketing_start_date": "20250725"}], "brand_name": "Olanzapine Intramuscular", "product_id": "0121-1072_1e5f9343-d43d-4ff7-b1ae-b6358640bbba", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0121-1072", "generic_name": "Olanzapine", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "brand_name_suffix": "Intramuscular", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/2mL"}], "application_number": "ANDA211072", "marketing_category": "ANDA", "marketing_start_date": "20250725", "listing_expiration_date": "20261231"}