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, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-083
Product ID 33342-083_54e61f27-1a30-4d62-8709-f7fe4023eb0f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203044
Listing Expiration 2027-12-31
Marketing Start 2015-02-27

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342083
Hyphenated Format 33342-083

Supplemental Identifiers

UPC
0333342083128 0333342086129 0333342084125
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 ANDA203044 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-07)
  • 100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-11)
  • 10 BLISTER PACK in 1 CARTON (33342-083-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 1000 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-44)
source: ndc

Packages (4)

33342-083-07 30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-07) 33342-083-11 100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-11) 33342-083-12 10 BLISTER PACK in 1 CARTON (33342-083-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 33342-083-44 1000 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-44)

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": "54e61f27-1a30-4d62-8709-f7fe4023eb0f", "openfda": {"nui": ["N0000175430"], "upc": ["0333342083128", "0333342086129", "0333342084125"], "unii": ["N7U69T4SZR"], "spl_set_id": ["df43938a-3469-40eb-8166-f0a2fd29d6d8"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-07)", "package_ndc": "33342-083-07", "marketing_start_date": "20150227"}, {"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-11)", "package_ndc": "33342-083-11", "marketing_start_date": "20150227"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-083-12)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "33342-083-12", "marketing_start_date": "20150227"}, {"sample": false, "description": "1000 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-44)", "package_ndc": "33342-083-44", "marketing_start_date": "20150227"}], "brand_name": "Olanzapine", "product_id": "33342-083_54e61f27-1a30-4d62-8709-f7fe4023eb0f", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "33342-083", "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": "ANDA203044", "marketing_category": "ANDA", "marketing_start_date": "20150227", "listing_expiration_date": "20271231"}