clozapine

Generic: clozapine

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clozapine
Generic Name clozapine
Labeler accord healthcare inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clozapine 100 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-142
Product ID 16729-142_40aa4dd3-36ca-1132-e063-6394a90a268d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202873
Listing Expiration 2026-12-31
Marketing Start 2017-04-10

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729142
Hyphenated Format 16729-142

Supplemental Identifiers

RxCUI
197535 197536
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 ANDA202873 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16729-142-01)
  • 500 TABLET in 1 BOTTLE (16729-142-16)
source: ndc

Packages (2)

16729-142-01 100 TABLET in 1 BOTTLE (16729-142-01) 16729-142-16 500 TABLET in 1 BOTTLE (16729-142-16)

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": "40aa4dd3-36ca-1132-e063-6394a90a268d", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["197535", "197536"], "spl_set_id": ["25c0c6d5-f7b0-48e4-e054-00144ff8d46c"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16729-142-01)", "package_ndc": "16729-142-01", "marketing_start_date": "20170410"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16729-142-16)", "package_ndc": "16729-142-16", "marketing_start_date": "20170517"}], "brand_name": "Clozapine", "product_id": "16729-142_40aa4dd3-36ca-1132-e063-6394a90a268d", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "16729-142", "generic_name": "clozapine", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clozapine", "active_ingredients": [{"name": "CLOZAPINE", "strength": "100 mg/1"}], "application_number": "ANDA202873", "marketing_category": "ANDA", "marketing_start_date": "20170410", "listing_expiration_date": "20261231"}