clozapine

Generic: clozapine

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clozapine
Generic Name clozapine
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clozapine 100 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-3568
Product ID 55154-3568_1e35b287-61c0-404c-be74-0d27536d1298
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206433
Listing Expiration 2027-12-31
Marketing Start 2016-11-29

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551543568
Hyphenated Format 55154-3568

Supplemental Identifiers

RxCUI
197535
UPC
0055154356800
UNII
J60AR2IKIC
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 clozapine (source: ndc)
Generic Name clozapine (source: ndc)
Application Number ANDA206433 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-3568-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-3568-0 10 BLISTER PACK in 1 BAG (55154-3568-0) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

clozapine (100 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": "1e35b287-61c0-404c-be74-0d27536d1298", "openfda": {"nui": ["N0000175430"], "upc": ["0055154356800"], "unii": ["J60AR2IKIC"], "rxcui": ["197535"], "spl_set_id": ["7c748f8a-73ce-4bd3-aa30-9c66657f06ec"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-3568-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-3568-0", "marketing_start_date": "20161129"}], "brand_name": "CLOZAPINE", "product_id": "55154-3568_1e35b287-61c0-404c-be74-0d27536d1298", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "55154-3568", "generic_name": "CLOZAPINE", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOZAPINE", "active_ingredients": [{"name": "CLOZAPINE", "strength": "100 mg/1"}], "application_number": "ANDA206433", "marketing_category": "ANDA", "marketing_start_date": "20161129", "listing_expiration_date": "20271231"}