olanzapine

Generic: olanzapine

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler lannett company, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 20 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-3164
Product ID 0527-3164_002da62b-aec3-8e2a-e063-6294a90a5efc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208146
Listing Expiration 2026-12-31
Marketing Start 2023-05-30

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05273164
Hyphenated Format 0527-3164

Supplemental Identifiers

RxCUI
312076 314155 351107 351108
UPC
0305273163323 0305273164320 0305273161329 0305273162326
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 ANDA208146 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0527-3164-32)
source: ndc

Packages (1)

0527-3164-32 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0527-3164-32)

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": "002da62b-aec3-8e2a-e063-6294a90a5efc", "openfda": {"nui": ["N0000175430"], "upc": ["0305273163323", "0305273164320", "0305273161329", "0305273162326"], "unii": ["N7U69T4SZR"], "rxcui": ["312076", "314155", "351107", "351108"], "spl_set_id": ["002dd00f-7946-ea4f-e063-6294a90a5916"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0527-3164-32)", "package_ndc": "0527-3164-32", "marketing_start_date": "20230701"}], "brand_name": "Olanzapine", "product_id": "0527-3164_002da62b-aec3-8e2a-e063-6294a90a5efc", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0527-3164", "generic_name": "Olanzapine", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "20 mg/1"}], "application_number": "ANDA208146", "marketing_category": "ANDA", "marketing_start_date": "20230530", "listing_expiration_date": "20261231"}