clozapine

Generic: clozapine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name clozapine
Generic Name clozapine
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

clozapine 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7087
Product ID 0904-7087_3f7b2119-695f-4b57-b505-b07a8f9cc065
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206433
Listing Expiration 2027-12-31
Marketing Start 2016-11-29

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047087
Hyphenated Format 0904-7087

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7087-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7087-61 100 BLISTER PACK in 1 CARTON (0904-7087-61) / 1 TABLET 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": "3f7b2119-695f-4b57-b505-b07a8f9cc065", "openfda": {"nui": ["N0000175430"], "unii": ["J60AR2IKIC"], "rxcui": ["197535", "197536", "309374", "429212"], "spl_set_id": ["9db7aefb-f607-4158-a310-181e631bc648"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7087-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7087-61", "marketing_start_date": "20161129"}], "brand_name": "CLOZAPINE", "product_id": "0904-7087_3f7b2119-695f-4b57-b505-b07a8f9cc065", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0904-7087", "generic_name": "CLOZAPINE", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CLOZAPINE", "active_ingredients": [{"name": "CLOZAPINE", "strength": "100 mg/1"}], "application_number": "ANDA206433", "marketing_category": "ANDA", "marketing_start_date": "20161129", "listing_expiration_date": "20271231"}