olanzapine

Generic: olanzapine

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

olanzapine 2.5 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-478
Product ID 72189-478_2c4e094c-5799-f564-e063-6294a90ac3f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202862
Listing Expiration 2026-12-31
Marketing Start 2023-05-30

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189478
Hyphenated Format 72189-478

Supplemental Identifiers

RxCUI
200034
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 ANDA202862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-478-30)
source: ndc

Packages (1)

72189-478-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-478-30)

Ingredients (1)

olanzapine (2.5 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": "2c4e094c-5799-f564-e063-6294a90ac3f9", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["200034"], "spl_set_id": ["fcec190f-b865-c5d3-e053-6394a90a7e45"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-478-30)", "package_ndc": "72189-478-30", "marketing_start_date": "20230530"}], "brand_name": "Olanzapine", "product_id": "72189-478_2c4e094c-5799-f564-e063-6294a90ac3f9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "72189-478", "generic_name": "Olanzapine", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "2.5 mg/1"}], "application_number": "ANDA202862", "marketing_category": "ANDA", "marketing_start_date": "20230530", "listing_expiration_date": "20261231"}