olanzapine

Generic: olanzapine

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

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-068
Product ID 33342-068_3cb20bd0-3dd5-4742-b2d6-bfbeb8878d31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202862
Listing Expiration 2026-12-31
Marketing Start 2014-08-22

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342068
Hyphenated Format 33342-068

Supplemental Identifiers

RxCUI
200034 283639 312077 312078 312079 314154
UPC
0333342067074 0333342070074 0333342069078 0333342072078 0333342071071 0333342068071
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 ANDA202862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-068-07)
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-068-11)
  • 10 BLISTER PACK in 1 CARTON (33342-068-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1000 TABLET, FILM COATED in 1 BOTTLE (33342-068-44)
source: ndc

Packages (4)

33342-068-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-068-07) 33342-068-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-068-11) 33342-068-12 10 BLISTER PACK in 1 CARTON (33342-068-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK 33342-068-44 1000 TABLET, FILM COATED in 1 BOTTLE (33342-068-44)

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": "3cb20bd0-3dd5-4742-b2d6-bfbeb8878d31", "openfda": {"nui": ["N0000175430"], "upc": ["0333342067074", "0333342070074", "0333342069078", "0333342072078", "0333342071071", "0333342068071"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312077", "312078", "312079", "314154"], "spl_set_id": ["8e095987-bdea-42f2-9550-c7155cf07d30"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-068-07)", "package_ndc": "33342-068-07", "marketing_start_date": "20140822"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-068-11)", "package_ndc": "33342-068-11", "marketing_start_date": "20140822"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-068-12)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "33342-068-12", "marketing_start_date": "20140822"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (33342-068-44)", "package_ndc": "33342-068-44", "marketing_start_date": "20140822"}], "brand_name": "Olanzapine", "product_id": "33342-068_3cb20bd0-3dd5-4742-b2d6-bfbeb8878d31", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "33342-068", "generic_name": "Olanzapine", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA202862", "marketing_category": "ANDA", "marketing_start_date": "20140822", "listing_expiration_date": "20261231"}