olanzapine

Generic: olanzapine

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8244
Product ID 0615-8244_23d2c50e-1be1-4357-bb2f-a9903ba4a43b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202862
Listing Expiration 2026-12-31
Marketing Start 2014-08-22

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158244
Hyphenated Format 0615-8244

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 314154
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
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8244-05)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8244-39)
source: ndc

Packages (2)

0615-8244-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8244-05) 0615-8244-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8244-39)

Ingredients (1)

olanzapine (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": "23d2c50e-1be1-4357-bb2f-a9903ba4a43b", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "314154"], "spl_set_id": ["87b7fb23-c9b7-433f-bd17-cd3e91714c27"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8244-05)", "package_ndc": "0615-8244-05", "marketing_start_date": "20240724"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8244-39)", "package_ndc": "0615-8244-39", "marketing_start_date": "20181102"}], "brand_name": "Olanzapine", "product_id": "0615-8244_23d2c50e-1be1-4357-bb2f-a9903ba4a43b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0615-8244", "generic_name": "Olanzapine", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA202862", "marketing_category": "ANDA", "marketing_start_date": "20140822", "listing_expiration_date": "20261231"}