versacloz

Generic: clozapine

Labeler: trupharma llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name versacloz
Generic Name clozapine
Labeler trupharma llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

clozapine 50 mg/mL

Manufacturer
TruPharma LLC

Identifiers & Regulatory

Product NDC 52817-601
Product ID 52817-601_38837e2a-084f-4179-e063-6394a90afd45
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203479
Listing Expiration 2026-12-31
Marketing Start 2018-06-15

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52817601
Hyphenated Format 52817-601

Supplemental Identifiers

RxCUI
1369825 1369831
UPC
0352817601384
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 versacloz (source: ndc)
Generic Name clozapine (source: ndc)
Application Number NDA203479 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (52817-601-38) / 100 mL in 1 BOTTLE
source: ndc

Packages (1)

52817-601-38 1 BOTTLE in 1 BOX (52817-601-38) / 100 mL in 1 BOTTLE

Ingredients (1)

clozapine (50 mg/mL)

Linked Drug Pages (1)

VERSACLOZ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38837e2a-084f-4179-e063-6394a90afd45", "openfda": {"nui": ["N0000175430"], "upc": ["0352817601384"], "unii": ["J60AR2IKIC"], "rxcui": ["1369825", "1369831"], "spl_set_id": ["2592c9a8-fd74-4e0d-a895-b07b014cf355"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["TruPharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (52817-601-38)  / 100 mL in 1 BOTTLE", "package_ndc": "52817-601-38", "marketing_start_date": "20180615"}], "brand_name": "VERSACLOZ", "product_id": "52817-601_38837e2a-084f-4179-e063-6394a90afd45", "dosage_form": "SUSPENSION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "52817-601", "generic_name": "Clozapine", "labeler_name": "TruPharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VERSACLOZ", "active_ingredients": [{"name": "CLOZAPINE", "strength": "50 mg/mL"}], "application_number": "NDA203479", "marketing_category": "NDA", "marketing_start_date": "20180615", "listing_expiration_date": "20261231"}