clozaril

Generic: clozapine

Labeler: hls therapeutics (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name clozaril
Generic Name clozapine
Labeler hls therapeutics (usa), inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clozapine 100 mg/1

Manufacturer
HLS Therapeutics (USA), Inc.

Identifiers & Regulatory

Product NDC 69809-0127
Product ID 69809-0127_14601465-eda2-4063-b606-cb6cfcaaca3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019758
Listing Expiration 2026-12-31
Marketing Start 2016-05-06

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 698090127
Hyphenated Format 69809-0127

Supplemental Identifiers

RxCUI
104775 104776 197535 197536
UPC
0369809012752 0369809012653
UNII
J60AR2IKIC
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 clozaril (source: ndc)
Generic Name clozapine (source: ndc)
Application Number NDA019758 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (69809-0127-5)
source: ndc

Packages (1)

69809-0127-5 100 TABLET in 1 BOTTLE (69809-0127-5)

Ingredients (1)

clozapine (100 mg/1)

Linked Drug Pages (1)

Clozaril ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "14601465-eda2-4063-b606-cb6cfcaaca3d", "openfda": {"nui": ["N0000175430"], "upc": ["0369809012752", "0369809012653"], "unii": ["J60AR2IKIC"], "rxcui": ["104775", "104776", "197535", "197536"], "spl_set_id": ["90876802-0e3a-44c9-9ff7-1754dfbe736a"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["HLS Therapeutics (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (69809-0127-5)", "package_ndc": "69809-0127-5", "marketing_start_date": "20160506"}], "brand_name": "Clozaril", "product_id": "69809-0127_14601465-eda2-4063-b606-cb6cfcaaca3d", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "69809-0127", "generic_name": "clozapine", "labeler_name": "HLS Therapeutics (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clozaril", "active_ingredients": [{"name": "CLOZAPINE", "strength": "100 mg/1"}], "application_number": "NDA019758", "marketing_category": "NDA", "marketing_start_date": "20160506", "listing_expiration_date": "20261231"}