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, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1550
Product ID 67046-1550_325d7012-77bd-83af-e063-6294a90a52ef
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091265
Listing Expiration 2026-12-31
Marketing Start 2025-04-09

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461550
Hyphenated Format 67046-1550

Supplemental Identifiers

RxCUI
314155
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 ANDA091265 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (67046-1550-3)
source: ndc

Packages (1)

67046-1550-3 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (67046-1550-3)

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": "325d7012-77bd-83af-e063-6294a90a52ef", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["314155"], "spl_set_id": ["325d5d69-5133-79ea-e063-6294a90afdd0"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (67046-1550-3)", "package_ndc": "67046-1550-3", "marketing_start_date": "20250409"}], "brand_name": "Olanzapine", "product_id": "67046-1550_325d7012-77bd-83af-e063-6294a90a52ef", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "67046-1550", "generic_name": "Olanzapine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "5 mg/1"}], "application_number": "ANDA091265", "marketing_category": "ANDA", "marketing_start_date": "20250409", "listing_expiration_date": "20261231"}