ziprasidone mesylate

Generic: ziprasidone mesylate

Labeler: steriscience specialties private limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ziprasidone mesylate
Generic Name ziprasidone mesylate
Labeler steriscience specialties private limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR
Active Ingredients

ziprasidone mesylate 20 mg/mL

Manufacturer
STERISCIENCE SPECIALTIES PRIVATE LIMITED

Identifiers & Regulatory

Product NDC 82449-004
Product ID 82449-004_3eebc107-3b95-1b1e-e063-6394a90afed2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217595
Listing Expiration 2026-12-31
Marketing Start 2025-12-19

Pharmacologic Class

Classes
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82449004
Hyphenated Format 82449-004

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 ANDA217595 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

82449-004-01 1 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01) / 1 mL in 1 VIAL, SINGLE-DOSE 82449-004-02 10 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02) / 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": "3eebc107-3b95-1b1e-e063-6394a90afed2", "openfda": {"unii": ["3X6SAX83JZ"], "rxcui": ["351223"], "spl_set_id": ["1ffd16c3-25ac-4839-9ea9-4efd32926b95"], "manufacturer_name": ["STERISCIENCE SPECIALTIES PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "82449-004-01", "marketing_start_date": "20251219"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "82449-004-02", "marketing_start_date": "20251219"}], "brand_name": "Ziprasidone Mesylate", "product_id": "82449-004_3eebc107-3b95-1b1e-e063-6394a90afed2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "82449-004", "generic_name": "ziprasidone mesylate", "labeler_name": "STERISCIENCE SPECIALTIES PRIVATE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ziprasidone Mesylate", "active_ingredients": [{"name": "ZIPRASIDONE MESYLATE", "strength": "20 mg/mL"}], "application_number": "ANDA217595", "marketing_category": "ANDA", "marketing_start_date": "20251219", "listing_expiration_date": "20261231"}