clozapine

Generic: clozapine

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clozapine
Generic Name clozapine
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clozapine 25 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-404
Product ID 60687-404_3de71656-5df7-240a-e063-6294a90a303a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206433
Listing Expiration 2026-12-31
Marketing Start 2019-01-02

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687404
Hyphenated Format 60687-404

Supplemental Identifiers

RxCUI
197535 197536 309374 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 ANDA206433 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-404-01) / 1 TABLET in 1 BLISTER PACK (60687-404-11)
source: ndc

Packages (1)

60687-404-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-404-01) / 1 TABLET in 1 BLISTER PACK (60687-404-11)

Ingredients (1)

clozapine (25 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": "3de71656-5df7-240a-e063-6294a90a303a", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["197535", "197536", "309374", "429212"], "spl_set_id": ["d36c298b-7292-46e0-898f-43d3e11c3cf4"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-404-01)  / 1 TABLET in 1 BLISTER PACK (60687-404-11)", "package_ndc": "60687-404-01", "marketing_start_date": "20190102"}], "brand_name": "Clozapine", "product_id": "60687-404_3de71656-5df7-240a-e063-6294a90a303a", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "60687-404", "generic_name": "Clozapine", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clozapine", "active_ingredients": [{"name": "CLOZAPINE", "strength": "25 mg/1"}], "application_number": "ANDA206433", "marketing_category": "ANDA", "marketing_start_date": "20190102", "listing_expiration_date": "20261231"}