olanzapine

Generic: olanzapine

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 15 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5247
Product ID 0093-5247_cca528be-51eb-41ca-881a-0e57d49cf94a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077243
Listing Expiration 2027-12-31
Marketing Start 2012-01-24

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00935247
Hyphenated Format 0093-5247

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 ANDA077243 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0093-5247-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5247-19)
source: ndc

Packages (1)

0093-5247-65 30 BLISTER PACK in 1 CARTON (0093-5247-65) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5247-19)

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": "cca528be-51eb-41ca-881a-0e57d49cf94a", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312076", "314155", "351107", "351108"], "spl_set_id": ["dd0b2525-4e2f-44fc-9302-0ae4ebb1e135"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0093-5247-65)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5247-19)", "package_ndc": "0093-5247-65", "marketing_start_date": "20120224"}], "brand_name": "Olanzapine", "product_id": "0093-5247_cca528be-51eb-41ca-881a-0e57d49cf94a", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0093-5247", "generic_name": "Olanzapine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA077243", "marketing_category": "ANDA", "marketing_start_date": "20120124", "listing_expiration_date": "20271231"}