olanzapine

Generic: olanzapine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-844
Product ID 63187-844_e818889d-6a4e-473d-90cc-f817ffece059
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090798
Listing Expiration 2026-12-31
Marketing Start 2012-04-23

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187844
Hyphenated Format 63187-844

Supplemental Identifiers

RxCUI
312078
UNII
N7U69T4SZR
NUI
N0000175430

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 ANDA090798 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE (63187-844-03)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-844-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-844-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-844-90)
source: ndc

Packages (4)

63187-844-03 3 TABLET, FILM COATED in 1 BOTTLE (63187-844-03) 63187-844-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-844-30) 63187-844-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-844-60) 63187-844-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-844-90)

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": "e818889d-6a4e-473d-90cc-f817ffece059", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312078"], "spl_set_id": ["7772a4c2-1fb1-412b-9e3b-ef3d693517a2"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (63187-844-03)", "package_ndc": "63187-844-03", "marketing_start_date": "20170501"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-844-30)", "package_ndc": "63187-844-30", "marketing_start_date": "20120423"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-844-60)", "package_ndc": "63187-844-60", "marketing_start_date": "20120423"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-844-90)", "package_ndc": "63187-844-90", "marketing_start_date": "20170501"}], "brand_name": "Olanzapine", "product_id": "63187-844_e818889d-6a4e-473d-90cc-f817ffece059", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "63187-844", "generic_name": "Olanzapine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA090798", "marketing_category": "ANDA", "marketing_start_date": "20120423", "listing_expiration_date": "20261231"}