clozapine

Generic: clozapine

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

Drug Facts

Product Profile

Brand Name clozapine
Generic Name clozapine
Labeler mylan pharmaceuticals inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

clozapine 100 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3815
Product ID 0378-3815_92b67f95-a54d-49ab-934d-e1038f82b8fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201824
Listing Expiration 2026-12-31
Marketing Start 2015-11-02

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03783815
Hyphenated Format 0378-3815

Supplemental Identifiers

RxCUI
476177 476179 996921 1006801
UPC
0303783817019 0303783816012
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 ANDA201824 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3815-01)
source: ndc

Packages (1)

0378-3815-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3815-01)

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": "92b67f95-a54d-49ab-934d-e1038f82b8fb", "openfda": {"nui": ["N0000175430"], "upc": ["0303783817019", "0303783816012"], "unii": ["J60AR2IKIC"], "rxcui": ["476177", "476179", "996921", "1006801"], "spl_set_id": ["9ae4b8e4-d8b1-4f01-bb4c-cd1cea90b219"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3815-01)", "package_ndc": "0378-3815-01", "marketing_start_date": "20151102"}], "brand_name": "Clozapine", "product_id": "0378-3815_92b67f95-a54d-49ab-934d-e1038f82b8fb", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "0378-3815", "generic_name": "clozapine", "labeler_name": "Mylan Pharmaceuticals 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": "20151102", "listing_expiration_date": "20261231"}