olanzapine

Generic: olanzapine

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 20 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-090
Product ID 13668-090_1a64829a-2434-4c8d-8e58-9b28758e4b88
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091415
Listing Expiration 2027-12-31
Marketing Start 2011-10-25

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668090
Hyphenated Format 13668-090

Supplemental Identifiers

RxCUI
200034 283639 312076 312077 312078 312079 314154 314155 351107 351108
UPC
0313668088304 0313668170306 0313668169300 0313668171303 0313668168303 0313668166309 0313668090307 0313668089301 0313668167306 0313668086300
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 ANDA091415 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-05)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-30)
  • 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-90)
source: ndc

Packages (3)

13668-090-05 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-05) 13668-090-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-30) 13668-090-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-90)

Ingredients (1)

olanzapine (20 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": "1a64829a-2434-4c8d-8e58-9b28758e4b88", "openfda": {"nui": ["N0000175430"], "upc": ["0313668088304", "0313668170306", "0313668169300", "0313668171303", "0313668168303", "0313668166309", "0313668090307", "0313668089301", "0313668167306", "0313668086300"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312076", "312077", "312078", "312079", "314154", "314155", "351107", "351108"], "spl_set_id": ["2cb1bebe-0ced-46d8-bf21-c28a9acc4a15"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-05)", "package_ndc": "13668-090-05", "marketing_start_date": "20111025"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-30)", "package_ndc": "13668-090-30", "marketing_start_date": "20111025"}, {"sample": false, "description": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (13668-090-90)", "package_ndc": "13668-090-90", "marketing_start_date": "20111025"}], "brand_name": "OLANZAPINE", "product_id": "13668-090_1a64829a-2434-4c8d-8e58-9b28758e4b88", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "13668-090", "generic_name": "OLANZAPINE", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OLANZAPINE", "active_ingredients": [{"name": "OLANZAPINE", "strength": "20 mg/1"}], "application_number": "ANDA091415", "marketing_category": "ANDA", "marketing_start_date": "20111025", "listing_expiration_date": "20271231"}