olanzapine

Generic: olanzapine

Labeler: hisun pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olanzapine
Generic Name olanzapine
Labeler hisun pharmaceuticals usa, inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

olanzapine 15 mg/15mg

Manufacturer
Hisun Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 42658-158
Product ID 42658-158_0bbf07bd-400e-4f2a-e063-6294a90a1ed4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206892
Listing Expiration 2026-12-31
Marketing Start 2025-01-01

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42658158
Hyphenated Format 42658-158

Supplemental Identifiers

RxCUI
200034 283639 312076 312077 312078 312079 314154 314155 351107 351108
UPC
0342658158017 0342658150011 0342658155016 0342658153012 0342658157010 0342658152015 0342658159014 0342658156013 0342658154019 0342658151018
UNII
N7U69T4SZR
NUI
N0000175430

Packaging Origin

Original Packager
true

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 ANDA206892 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/15mg
source: ndc
Packaging
  • 450 mg in 1 BOTTLE (42658-158-01)
  • 1350 mg in 1 BOTTLE (42658-158-04)
  • 7500 mg in 1 BOTTLE (42658-158-07)
source: ndc

Packages (3)

42658-158-01 450 mg in 1 BOTTLE (42658-158-01) 42658-158-04 1350 mg in 1 BOTTLE (42658-158-04) 42658-158-07 7500 mg in 1 BOTTLE (42658-158-07)

Ingredients (1)

olanzapine (15 mg/15mg)

Linked Drug Pages (1)

Olanzapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0bbf07bd-400e-4f2a-e063-6294a90a1ed4", "openfda": {"nui": ["N0000175430"], "upc": ["0342658158017", "0342658150011", "0342658155016", "0342658153012", "0342658157010", "0342658152015", "0342658159014", "0342658156013", "0342658154019", "0342658151018"], "unii": ["N7U69T4SZR"], "rxcui": ["200034", "283639", "312076", "312077", "312078", "312079", "314154", "314155", "351107", "351108"], "spl_set_id": ["0bbf07bd-400d-4f2a-e063-6294a90a1ed4"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Hisun Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "450 mg in 1 BOTTLE (42658-158-01)", "package_ndc": "42658-158-01", "marketing_start_date": "20250101"}, {"sample": false, "description": "1350 mg in 1 BOTTLE (42658-158-04)", "package_ndc": "42658-158-04", "marketing_start_date": "20250101"}, {"sample": false, "description": "7500 mg in 1 BOTTLE (42658-158-07)", "package_ndc": "42658-158-07", "marketing_start_date": "20250101"}], "brand_name": "Olanzapine", "product_id": "42658-158_0bbf07bd-400e-4f2a-e063-6294a90a1ed4", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "42658-158", "generic_name": "Olanzapine", "labeler_name": "Hisun Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olanzapine", "active_ingredients": [{"name": "OLANZAPINE", "strength": "15 mg/15mg"}], "application_number": "ANDA206892", "marketing_category": "ANDA", "marketing_start_date": "20250101", "listing_expiration_date": "20261231"}