NDC codes

FDA NDC Directory
Product NDC (as listed)43598-848Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43598-0848Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
43598-848-5843598084858435980848581 VIAL, SINGLE-DOSE in 1 CARTON (43598-848-58) / 1 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 24, 2020

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
Dr.Reddy's Laboratories, Inc.NDC labeler code 43598
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211908
Marketing start
Listing expires
Identifiers
Product ID 43598-848_44d8fcde-2e03-b6e8-d5dd-d062e075be8cSPL ID 44d8fcde-2e03-b6e8-d5dd-d062e075be8cSPL set ID 3cb79985-1207-602e-2dda-a118133b4c60RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N443598084858 followed by a unit qualifier and the quantity

Package 43598-0848-58. 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.

Full label on DailyMed (opens in a new tab)

About NDC 43598-848

What is NDC 43598-848?
43598-848 is the product NDC for ziprasidone mesylate, Ziprasidone mesylate 20 mg/mL injection, powder, lyophilized, for solution, listed with the FDA by Dr.Reddy's Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ziprasidone mesylate.
What is the active ingredient?
Ziprasidone mesylate.
Who is the labeler?
Dr.Reddy's Laboratories, Inc., NDC labeler code 43598. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ziprasidone mesylate?
7 other product NDCs are listed under this name. See all ziprasidone mesylate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other ziprasidone mesylate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ziprasidone mesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularREMEDYREPACK INC.70518-475570518-4755-00
Ziprasidone MesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularSTERISCIENCE SPECIALTIES PRIVATE LIMITED82449-00482449-0004-0182449-0004-02
ziprasidone mesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularNovadoz Pharmaceuticals LLC72205-20572205-0205-07
ziprasidone mesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularDr.Reddy's Laboratories, Inc.43598-06143598-0061-58
Ziprasidone MesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-156451662-1564-03
Ziprasidone MesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularFosun Pharma USA Inc.72266-16072266-0160-10
ziprasidone mesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularGland Pharma Limited68083-34068083-0340-01

Other NDCs under ANDA 211908

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 211908
ProductStrengthForm · routeLabelerProduct NDC
ziprasidone mesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularREMEDYREPACK INC.70518-4755
ziprasidone mesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularGland Pharma Limited68083-340
Ziprasidone MesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularHF Acquisition Co LLC, DBA HealthFirst51662-1564
ziprasidone mesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularDr.Reddy's Laboratories, Inc.43598-061
Ziprasidone MesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularFosun Pharma USA Inc.72266-160
Ziprasidone MesylateZiprasidone mesylate 20 mg/mLInjection, Powder, Lyophilized, For solutionIntramuscularFosun Pharma USA Inc.72266-160

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