olanzapine

Generic: olanzapine

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler upsher-smith laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

olanzapine 2.5 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 0832-6078
Product ID 0832-6078_8360dfb0-5f3a-4b86-8b46-fc89c12aad6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204319
Marketing Start 2016-01-27
Marketing End 2026-08-31

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08326078
Hyphenated Format 0832-6078

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
UPC
0308326078032 0308326082039 0308326081032 0308326079039 0308326083036 0308326080035
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 ANDA204319 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (0832-6078-03)
  • 500 TABLET in 1 BOTTLE (0832-6078-50)
source: ndc

Packages (2)

0832-6078-03 30 TABLET in 1 BOTTLE (0832-6078-03) 0832-6078-50 500 TABLET in 1 BOTTLE (0832-6078-50)

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": "8360dfb0-5f3a-4b86-8b46-fc89c12aad6b", "openfda": {"nui": ["N0000175430"], "upc": ["0308326078032", "0308326082039", "0308326081032", "0308326079039", "0308326083036", "0308326080035"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["dbe23f33-9e7d-49a7-8528-fa290661a96f"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (0832-6078-03)", "package_ndc": "0832-6078-03", "marketing_end_date": "20260831", "marketing_start_date": "20240815"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (0832-6078-50)", "package_ndc": "0832-6078-50", "marketing_end_date": "20260831", "marketing_start_date": "20240815"}], "brand_name": "Olanzapine", "product_id": "0832-6078_8360dfb0-5f3a-4b86-8b46-fc89c12aad6b", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0832-6078", "generic_name": "Olanzapine", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "2.5 mg/1"}], "application_number": "ANDA204319", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20160127"}