olanzapine

Generic: olanzapine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

olanzapine 10 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1583
Product ID 67046-1583_3ed7888b-d94b-61e3-e063-6394a90a1de4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210022
Listing Expiration 2026-12-31
Marketing Start 2025-09-15

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461583
Hyphenated Format 67046-1583

Supplemental Identifiers

RxCUI
314154
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 ANDA210022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1583-3)
source: ndc

Packages (1)

67046-1583-3 30 TABLET in 1 BLISTER PACK (67046-1583-3)

Ingredients (1)

olanzapine (10 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": "3ed7888b-d94b-61e3-e063-6394a90a1de4", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["314154"], "spl_set_id": ["3ed78a7d-4014-d280-e063-6294a90a8ee9"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1583-3)", "package_ndc": "67046-1583-3", "marketing_start_date": "20250915"}], "brand_name": "Olanzapine", "product_id": "67046-1583_3ed7888b-d94b-61e3-e063-6394a90a1de4", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67046-1583", "generic_name": "Olanzapine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "10 mg/1"}], "application_number": "ANDA210022", "marketing_category": "ANDA", "marketing_start_date": "20250915", "listing_expiration_date": "20261231"}