olanzapine

Generic: olanzapine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 71335-0534
Product ID 71335-0534_337b1be2-1abe-ac1f-e063-6294a90a13a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202862
Listing Expiration 2026-12-31
Marketing Start 2014-08-22

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713350534
Hyphenated Format 71335-0534

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 ANDA202862 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (71335-0534-1)
  • 15 TABLET, FILM COATED in 1 BOTTLE (71335-0534-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE (71335-0534-3)
  • 90 TABLET, FILM COATED in 1 BOTTLE (71335-0534-4)
  • 120 TABLET, FILM COATED in 1 BOTTLE (71335-0534-5)
source: ndc

Packages (5)

71335-0534-1 30 TABLET, FILM COATED in 1 BOTTLE (71335-0534-1) 71335-0534-2 15 TABLET, FILM COATED in 1 BOTTLE (71335-0534-2) 71335-0534-3 60 TABLET, FILM COATED in 1 BOTTLE (71335-0534-3) 71335-0534-4 90 TABLET, FILM COATED in 1 BOTTLE (71335-0534-4) 71335-0534-5 120 TABLET, FILM COATED in 1 BOTTLE (71335-0534-5)

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": "337b1be2-1abe-ac1f-e063-6294a90a13a7", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["312078"], "spl_set_id": ["8586e828-34e7-4eb4-a933-6c688927478f"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (71335-0534-1)", "package_ndc": "71335-0534-1", "marketing_start_date": "20180221"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (71335-0534-2)", "package_ndc": "71335-0534-2", "marketing_start_date": "20211227"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (71335-0534-3)", "package_ndc": "71335-0534-3", "marketing_start_date": "20210601"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71335-0534-4)", "package_ndc": "71335-0534-4", "marketing_start_date": "20211227"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (71335-0534-5)", "package_ndc": "71335-0534-5", "marketing_start_date": "20211227"}], "brand_name": "Olanzapine", "product_id": "71335-0534_337b1be2-1abe-ac1f-e063-6294a90a13a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "71335-0534", "generic_name": "Olanzapine", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA202862", "marketing_category": "ANDA", "marketing_start_date": "20140822", "listing_expiration_date": "20261231"}