olanzapine

Generic: olanzapine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

olanzapine 15 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-658
Product ID 65862-658_4f9fe058-fa71-4b85-9bad-482ade6b085e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203708
Listing Expiration 2027-12-31
Marketing Start 2014-05-15

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862658
Hyphenated Format 65862-658

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 ANDA203708 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (65862-658-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-658-10)
source: ndc

Packages (1)

65862-658-03 3 BLISTER PACK in 1 CARTON (65862-658-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-658-10)

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": "4f9fe058-fa71-4b85-9bad-482ade6b085e", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312076", "314155", "351107", "351108"], "spl_set_id": ["4d768cfe-3b20-4127-95b9-b4151b28afcc"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-658-03)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-658-10)", "package_ndc": "65862-658-03", "marketing_start_date": "20140515"}], "brand_name": "Olanzapine", "product_id": "65862-658_4f9fe058-fa71-4b85-9bad-482ade6b085e", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65862-658", "generic_name": "Olanzapine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "15 mg/1"}], "application_number": "ANDA203708", "marketing_category": "ANDA", "marketing_start_date": "20140515", "listing_expiration_date": "20271231"}