ziprasidone mesylate

Generic: ziprasidone mesylate

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

Drug Facts

Product Profile

Brand Name ziprasidone mesylate
Generic Name ziprasidone mesylate
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ziprasidone mesylate 20 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-340
Product ID 68083-340_dae5d774-0982-4b2b-8803-02bd0910d228
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211908
Listing Expiration 2026-12-31
Marketing Start 2019-12-26

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083340
Hyphenated Format 68083-340

Supplemental Identifiers

RxCUI
351223
UNII
3X6SAX83JZ

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 ziprasidone mesylate (source: ndc)
Generic Name ziprasidone mesylate (source: ndc)
Application Number ANDA211908 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

68083-340-01 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ziprasidone mesylate (20 mg/mL)

Linked Drug Pages (1)

ziprasidone mesylate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "dae5d774-0982-4b2b-8803-02bd0910d228", "openfda": {"unii": ["3X6SAX83JZ"], "rxcui": ["351223"], "spl_set_id": ["77a10f48-e300-465f-81b5-54be38daa4b3"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68083-340-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68083-340-01", "marketing_start_date": "20191226"}], "brand_name": "ziprasidone mesylate", "product_id": "68083-340_dae5d774-0982-4b2b-8803-02bd0910d228", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "68083-340", "generic_name": "ziprasidone mesylate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ziprasidone mesylate", "active_ingredients": [{"name": "ZIPRASIDONE MESYLATE", "strength": "20 mg/mL"}], "application_number": "ANDA211908", "marketing_category": "ANDA", "marketing_start_date": "20191226", "listing_expiration_date": "20261231"}