Dexrazoxane (dexrazoxane for injection) NDC 68083-195

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-195Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0195Add 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 NDC	11-digit (billing)	Package	Copy
68083-195-01	68083019501	1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIALMarketed from Dec 5, 2016

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): Dexrazoxane
Generic name (nonproprietary): dexrazoxane for injection
Active ingredients: Dexrazoxane hydrochloride — 500 mg/50mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Gland Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207321
Marketing start: Dec 5, 2016
Listing expires: Dec 31, 2026
Identifiers: Product ID 68083-195_31a8c608-3ad6-44fe-aec8-621a8b991677SPL ID 31a8c608-3ad6-44fe-aec8-621a8b991677SPL set ID c9c625fc-8852-4ed4-bcf2-63f46a706782RxCUI 1736585, 1736590UNII 5346058Q7SUPC 0368083388010, 0368083195014
Pharmacologic class: Cytoprotective Agent

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

N468083019501 followed by a unit qualifier and the quantity

Package 68083-0195-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 207321

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

FDA NDC Directory listings under ANDA 207321
Product	Strength	Form · route	Labeler	Product NDC
Dexrazoxanedexrazoxane for injection	Dexrazoxane hydrochloride 500 mg/50mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fosun Pharma USA Inc.	72266-101
Dexrazoxanedexrazoxane for injection	Dexrazoxane hydrochloride 250 mg/25mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fosun Pharma USA Inc.	72266-235
Dexrazoxanedexrazoxane for injection	Dexrazoxane hydrochloride 250 mg/25mL	Injection, Powder, Lyophilized, For solutionIntravenous	Gland Pharma Limited	68083-388
Dexrazoxanedexrazoxane for injection	Dexrazoxane hydrochloride 500 mg/50mL	Injection, Powder, Lyophilized, For solutionIntravenous	Almaject, Inc.	72611-716
Dexrazoxanedexrazoxane for injection	Dexrazoxane hydrochloride 500 mg/50mL	Injection, Powder, Lyophilized, For solutionIntravenous	Almaject, Inc.	72611-716