clozapine

Generic: clozapine

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clozapine
Generic Name clozapine
Labeler bryant ranch prepack
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clozapine 50 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2361
Product ID 63629-2361_41baa684-f0a3-4637-b6db-cf28aab76ba5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075713
Listing Expiration 2026-12-31
Marketing Start 2005-08-19

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636292361
Hyphenated Format 63629-2361

Supplemental Identifiers

RxCUI
429212
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 ANDA075713 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (63629-2361-1)
source: ndc

Packages (1)

63629-2361-1 100 TABLET in 1 BOTTLE (63629-2361-1)

Ingredients (1)

clozapine (50 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": "41baa684-f0a3-4637-b6db-cf28aab76ba5", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["429212"], "spl_set_id": ["9b035a6a-f5c1-43a8-9203-cc016dc6e422"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (63629-2361-1)", "package_ndc": "63629-2361-1", "marketing_start_date": "20050819"}], "brand_name": "CLOZAPINE", "product_id": "63629-2361_41baa684-f0a3-4637-b6db-cf28aab76ba5", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "63629-2361", "generic_name": "CLOZAPINE", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOZAPINE", "active_ingredients": [{"name": "CLOZAPINE", "strength": "50 mg/1"}], "application_number": "ANDA075713", "marketing_category": "ANDA", "marketing_start_date": "20050819", "listing_expiration_date": "20261231"}