olanzapine

Generic: olanzapine

Labeler: american regent, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler american regent, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

olanzapine 10 mg/2mL

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-0955
Product ID 0517-0955_ad82611b-9883-4583-95bd-17a021346db5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201741
Listing Expiration 2026-12-31
Marketing Start 2012-06-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05170955
Hyphenated Format 0517-0955

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 ANDA201741 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 10 mg/2mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0517-0955-01) / 2 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0517-0955-01 1 VIAL, GLASS in 1 CARTON (0517-0955-01) / 2 mL in 1 VIAL, GLASS

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": "ad82611b-9883-4583-95bd-17a021346db5", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["485968"], "spl_set_id": ["e9ac2bd3-dbff-4b1a-952f-da3909c6e4ee"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0517-0955-01)  / 2 mL in 1 VIAL, GLASS", "package_ndc": "0517-0955-01", "marketing_start_date": "20120627"}], "brand_name": "Olanzapine", "product_id": "0517-0955_ad82611b-9883-4583-95bd-17a021346db5", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0517-0955", "generic_name": "Olanzapine", "labeler_name": "American Regent, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/2mL"}], "application_number": "ANDA201741", "marketing_category": "ANDA", "marketing_start_date": "20120627", "listing_expiration_date": "20261231"}