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, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

clozapine 100 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-288
Product ID 51079-288_3a39cd16-5a3c-3d37-e063-6294a90abfc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201824
Listing Expiration 2026-12-31
Marketing Start 2016-09-26

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079288
Hyphenated Format 51079-288

Supplemental Identifiers

RxCUI
476177
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 ANDA201824 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 40 BLISTER PACK in 1 CARTON (51079-288-04) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51079-288-01)
source: ndc

Packages (1)

51079-288-04 40 BLISTER PACK in 1 CARTON (51079-288-04) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51079-288-01)

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": "3a39cd16-5a3c-3d37-e063-6294a90abfc2", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["476177"], "spl_set_id": ["976be6e3-a9db-49c6-9b02-1ab168cf17b1"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "40 BLISTER PACK in 1 CARTON (51079-288-04)  / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (51079-288-01)", "package_ndc": "51079-288-04", "marketing_start_date": "20160926"}], "brand_name": "Clozapine", "product_id": "51079-288_3a39cd16-5a3c-3d37-e063-6294a90abfc2", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "51079-288", "generic_name": "clozapine", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clozapine", "active_ingredients": [{"name": "CLOZAPINE", "strength": "100 mg/1"}], "application_number": "ANDA201824", "marketing_category": "ANDA", "marketing_start_date": "20160926", "listing_expiration_date": "20261231"}