olanzapine

Generic: olanzapine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler apotex corp.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 15 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3277
Product ID 60505-3277_997c6776-1ac1-bcb1-022c-2c5b6c277395
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091265
Listing Expiration 2026-12-31
Marketing Start 2011-10-24

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605053277
Hyphenated Format 60505-3277

Supplemental Identifiers

RxCUI
312076 314155 351107 351108
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 ANDA091265 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (60505-3277-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3277-3)
  • 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3277-8)
source: ndc

Packages (3)

60505-3277-0 10 BLISTER PACK in 1 CARTON (60505-3277-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 60505-3277-3 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3277-3) 60505-3277-8 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3277-8)

Ingredients (1)

olanzapine (15 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": "997c6776-1ac1-bcb1-022c-2c5b6c277395", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312076", "314155", "351107", "351108"], "spl_set_id": ["96165590-b287-0ed9-3723-752af59aedad"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (60505-3277-0)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "60505-3277-0", "marketing_start_date": "20111024"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3277-3)", "package_ndc": "60505-3277-3", "marketing_start_date": "20111024"}, {"sample": false, "description": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (60505-3277-8)", "package_ndc": "60505-3277-8", "marketing_start_date": "20111024"}], "brand_name": "Olanzapine", "product_id": "60505-3277_997c6776-1ac1-bcb1-022c-2c5b6c277395", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "60505-3277", "generic_name": "Olanzapine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA091265", "marketing_category": "ANDA", "marketing_start_date": "20111024", "listing_expiration_date": "20261231"}