clozapine

Generic: clozapine

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

Drug Facts

Product Profile

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

clozapine 12.5 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-5416
Product ID 0093-5416_1b735bc2-6341-40af-8696-e61621d91ee8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090308
Listing Expiration 2026-12-31
Marketing Start 2018-04-17

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00935416
Hyphenated Format 0093-5416

Supplemental Identifiers

RxCUI
476177 476179 721773 996921 1006801
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 clozapine (source: ndc)
Generic Name clozapine (source: ndc)
Application Number ANDA090308 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5416-01)
source: ndc

Packages (1)

0093-5416-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5416-01)

Ingredients (1)

clozapine (12.5 mg/1)

Linked Drug Pages (1)

Clozapine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1b735bc2-6341-40af-8696-e61621d91ee8", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["476177", "476179", "721773", "996921", "1006801"], "spl_set_id": ["6fccf4f7-2e30-4272-9800-225aaef20584"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (0093-5416-01)", "package_ndc": "0093-5416-01", "marketing_start_date": "20180417"}], "brand_name": "Clozapine", "product_id": "0093-5416_1b735bc2-6341-40af-8696-e61621d91ee8", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0093-5416", "generic_name": "Clozapine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clozapine", "active_ingredients": [{"name": "CLOZAPINE", "strength": "12.5 mg/1"}], "application_number": "ANDA090308", "marketing_category": "ANDA", "marketing_start_date": "20180417", "listing_expiration_date": "20261231"}