clozapine

Generic: clozapine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clozapine
Generic Name clozapine
Labeler aurobindo pharma limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

clozapine 100 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-262
Product ID 59651-262_5fe42ada-7ea2-4b77-bad5-93e1b1fb765d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212923
Listing Expiration 2026-12-31
Marketing Start 2024-12-12

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651262
Hyphenated Format 59651-262

Supplemental Identifiers

RxCUI
476177 476179 721773 996921 1006801
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 ANDA212923 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-262-01)
  • 8 BLISTER PACK in 1 CARTON (59651-262-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (2)

59651-262-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-262-01) 59651-262-48 8 BLISTER PACK in 1 CARTON (59651-262-48) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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": "5fe42ada-7ea2-4b77-bad5-93e1b1fb765d", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["476177", "476179", "721773", "996921", "1006801"], "spl_set_id": ["caf2d4a6-2a23-4992-a807-560c4204afc4"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-262-01)", "package_ndc": "59651-262-01", "marketing_start_date": "20241212"}, {"sample": false, "description": "8 BLISTER PACK in 1 CARTON (59651-262-48)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "59651-262-48", "marketing_start_date": "20241212"}], "brand_name": "Clozapine", "product_id": "59651-262_5fe42ada-7ea2-4b77-bad5-93e1b1fb765d", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "59651-262", "generic_name": "Clozapine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Clozapine", "active_ingredients": [{"name": "CLOZAPINE", "strength": "100 mg/1"}], "application_number": "ANDA212923", "marketing_category": "ANDA", "marketing_start_date": "20241212", "listing_expiration_date": "20261231"}