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
Routes
ORAL
Active Ingredients

clozapine 25 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-844
Product ID 65862-844_a46da176-2ed3-4b9a-b06f-efab2936a5ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206433
Listing Expiration 2026-12-31
Marketing Start 2016-11-29

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862844
Hyphenated Format 65862-844

Supplemental Identifiers

RxCUI
197535 197536 309374 429212
UPC
0365862844019 0365862845016
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 ANDA206433 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65862-844-01)
  • 500 TABLET in 1 BOTTLE (65862-844-05)
  • 10 BLISTER PACK in 1 CARTON (65862-844-78) / 10 TABLET in 1 BLISTER PACK (65862-844-10)
source: ndc

Packages (3)

65862-844-01 100 TABLET in 1 BOTTLE (65862-844-01) 65862-844-05 500 TABLET in 1 BOTTLE (65862-844-05) 65862-844-78 10 BLISTER PACK in 1 CARTON (65862-844-78) / 10 TABLET in 1 BLISTER PACK (65862-844-10)

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": "a46da176-2ed3-4b9a-b06f-efab2936a5ee", "openfda": {"nui": ["N0000175430"], "upc": ["0365862844019", "0365862845016"], "unii": ["J60AR2IKIC"], "rxcui": ["197535", "197536", "309374", "429212"], "spl_set_id": ["5021d643-32d2-4167-b5d8-90870e68a787"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65862-844-01)", "package_ndc": "65862-844-01", "marketing_start_date": "20161129"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (65862-844-05)", "package_ndc": "65862-844-05", "marketing_start_date": "20161129"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-844-78)  / 10 TABLET in 1 BLISTER PACK (65862-844-10)", "package_ndc": "65862-844-78", "marketing_start_date": "20161129"}], "brand_name": "CLOZAPINE", "product_id": "65862-844_a46da176-2ed3-4b9a-b06f-efab2936a5ee", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "65862-844", "generic_name": "CLOZAPINE", "labeler_name": "Aurobindo Pharma Limited", "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": "20161129", "listing_expiration_date": "20261231"}