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, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 15 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3114
Product ID 60505-3114_2dd39227-59ef-df97-a57e-d5a013dc132f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090798
Listing Expiration 2027-12-31
Marketing Start 2012-04-23

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605053114
Hyphenated Format 60505-3114

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
UPC
0360505311286 0360505311187 0360505311385 0360505311484 0360505314089 0360505311088
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 ANDA090798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (60505-3114-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (60505-3114-3)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (60505-3114-8)
source: ndc

Packages (3)

60505-3114-0 10 BLISTER PACK in 1 CARTON (60505-3114-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK 60505-3114-3 30 TABLET, FILM COATED in 1 BOTTLE (60505-3114-3) 60505-3114-8 1000 TABLET, FILM COATED in 1 BOTTLE (60505-3114-8)

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": "2dd39227-59ef-df97-a57e-d5a013dc132f", "openfda": {"nui": ["N0000175430"], "upc": ["0360505311286", "0360505311187", "0360505311385", "0360505311484", "0360505314089", "0360505311088"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["3347d1c8-04c9-5ce1-8cda-b38e0412b709"], "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 (60505-3114-0)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "60505-3114-0", "marketing_start_date": "20120423"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (60505-3114-3)", "package_ndc": "60505-3114-3", "marketing_start_date": "20120423"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (60505-3114-8)", "package_ndc": "60505-3114-8", "marketing_start_date": "20120423"}], "brand_name": "Olanzapine", "product_id": "60505-3114_2dd39227-59ef-df97-a57e-d5a013dc132f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "60505-3114", "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": "ANDA090798", "marketing_category": "ANDA", "marketing_start_date": "20120423", "listing_expiration_date": "20271231"}