olanzapine

Generic: olanzapine

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8722
Product ID 68788-8722_abb81337-86aa-40de-852c-f42dafe5cc56
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076255
Listing Expiration 2026-12-31
Marketing Start 2024-08-09

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888722
Hyphenated Format 68788-8722

Supplemental Identifiers

RxCUI
312078
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 ANDA076255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8722-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8722-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8722-9)
source: ndc

Packages (3)

68788-8722-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8722-3) 68788-8722-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8722-6) 68788-8722-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8722-9)

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": "abb81337-86aa-40de-852c-f42dafe5cc56", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312078"], "spl_set_id": ["d349d5b7-5658-46d6-9bba-e6f6361cebb9"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8722-3)", "package_ndc": "68788-8722-3", "marketing_start_date": "20240809"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8722-6)", "package_ndc": "68788-8722-6", "marketing_start_date": "20240809"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8722-9)", "package_ndc": "68788-8722-9", "marketing_start_date": "20240809"}], "brand_name": "Olanzapine", "product_id": "68788-8722_abb81337-86aa-40de-852c-f42dafe5cc56", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68788-8722", "generic_name": "Olanzapine", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA076255", "marketing_category": "ANDA", "marketing_start_date": "20240809", "listing_expiration_date": "20261231"}