Prescription drug · ANDA
ziprasidone mesylate NDC 68083-340
Ziprasidone mesylate 20 mg/mL · Injection, Powder, Lyophilized, For solution · Intramuscular · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-340-01 | 68083034001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-340-01) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 26, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- ziprasidone mesylate
- Generic name (nonproprietary)
- ziprasidone mesylate
- Active ingredients
- Ziprasidone mesylate — 20 mg/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intramuscular
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211908
- Marketing start
- Listing expires
- Identifiers
- Product ID 68083-340_dae5d774-0982-4b2b-8803-02bd0910d228SPL ID dae5d774-0982-4b2b-8803-02bd0910d228SPL set ID 77a10f48-e300-465f-81b5-54be38daa4b3RxCUI 351223UNII 3X6SAX83JZ
- Pharmacologic class
- Atypical Antipsychotic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N468083034001followed by a unit qualifier and the quantityPackage 68083-0340-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3) ]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether zipr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211908
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| ziprasidone mesylate | Ziprasidone mesylate 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular | Dr.Reddy's Laboratories, Inc. | 43598-848 |
| Ziprasidone Mesylate | Ziprasidone mesylate 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular | Fosun Pharma USA Inc. | 72266-160 |
| Ziprasidone Mesylate | Ziprasidone mesylate 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular | Fosun Pharma USA Inc. | 72266-160 |
| ziprasidone mesylate | Ziprasidone mesylate 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular | REMEDYREPACK INC. | 70518-4755 |
| Ziprasidone Mesylate | Ziprasidone mesylate 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular | HF Acquisition Co LLC, DBA HealthFirst | 51662-1564 |
| ziprasidone mesylate | Ziprasidone mesylate 20 mg/mL | Injection, Powder, Lyophilized, For solutionIntramuscular | Dr.Reddy's Laboratories, Inc. | 43598-061 |