clozapine

Generic: clozapine

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clozapine
Generic Name clozapine
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clozapine 50 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0972
Product ID 0378-0972_2e4e543f-9db4-4f0e-8c4f-dbef97c78e35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075417
Listing Expiration 2026-12-31
Marketing Start 2010-04-20

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780972
Hyphenated Format 0378-0972

Supplemental Identifiers

RxCUI
197535 197536 309374 429212
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 ANDA075417 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-0972-01)
source: ndc

Packages (1)

0378-0972-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0972-01)

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": "2e4e543f-9db4-4f0e-8c4f-dbef97c78e35", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["197535", "197536", "309374", "429212"], "spl_set_id": ["883b5d43-0339-7dc1-f775-93791fb9b978"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0972-01)", "package_ndc": "0378-0972-01", "marketing_start_date": "20100420"}], "brand_name": "Clozapine", "product_id": "0378-0972_2e4e543f-9db4-4f0e-8c4f-dbef97c78e35", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0378-0972", "generic_name": "clozapine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clozapine", "active_ingredients": [{"name": "CLOZAPINE", "strength": "50 mg/1"}], "application_number": "ANDA075417", "marketing_category": "ANDA", "marketing_start_date": "20100420", "listing_expiration_date": "20261231"}