olanzapine

Generic: olanzapine

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

olanzapine 2.5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3568
Product ID 70518-3568_3ac14e67-f3b3-8806-e063-6294a90aa0a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090798
Listing Expiration 2026-12-31
Marketing Start 2022-11-02

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183568
Hyphenated Format 70518-3568

Supplemental Identifiers

RxCUI
200034
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
  • 2.5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3568-0)
source: ndc

Packages (1)

70518-3568-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3568-0)

Ingredients (1)

olanzapine (2.5 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": "3ac14e67-f3b3-8806-e063-6294a90aa0a7", "openfda": {"nui": ["N0000175430"], "unii": ["N7U69T4SZR"], "rxcui": ["200034"], "spl_set_id": ["032e589c-47b1-4eb1-9466-8160297b81e9"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3568-0)", "package_ndc": "70518-3568-0", "marketing_start_date": "20221102"}], "brand_name": "Olanzapine", "product_id": "70518-3568_3ac14e67-f3b3-8806-e063-6294a90aa0a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "70518-3568", "generic_name": "Olanzapine", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "2.5 mg/1"}], "application_number": "ANDA090798", "marketing_category": "ANDA", "marketing_start_date": "20221102", "listing_expiration_date": "20261231"}