clozapine

Generic: clozapine

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

Drug Facts

Product Profile

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

clozapine 200 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-749
Product ID 51079-749_4358c8d6-f05a-65d8-e063-6294a90a422a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075417
Listing Expiration 2026-12-31
Marketing Start 2010-07-06

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079749
Hyphenated Format 51079-749

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-749-20) / 1 TABLET in 1 BLISTER PACK (51079-749-01)
source: ndc

Packages (1)

51079-749-20 100 BLISTER PACK in 1 CARTON (51079-749-20) / 1 TABLET in 1 BLISTER PACK (51079-749-01)

Ingredients (1)

clozapine (200 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": "4358c8d6-f05a-65d8-e063-6294a90a422a", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["197535", "197536", "309374"], "spl_set_id": ["d5c8a456-6f3c-4963-b321-4ed746f690e4"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-749-20)  / 1 TABLET in 1 BLISTER PACK (51079-749-01)", "package_ndc": "51079-749-20", "marketing_start_date": "20100706"}], "brand_name": "Clozapine", "product_id": "51079-749_4358c8d6-f05a-65d8-e063-6294a90a422a", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "51079-749", "generic_name": "clozapine", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clozapine", "active_ingredients": [{"name": "CLOZAPINE", "strength": "200 mg/1"}], "application_number": "ANDA075417", "marketing_category": "ANDA", "marketing_start_date": "20100706", "listing_expiration_date": "20261231"}