Mitomycin NDC 68083-502

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-502Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0502Add 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
68083-502-01	68083050201	1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) / 80 mL in 1 VIAL, SINGLE-DOSEMarketed from Nov 22, 2022

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): Mitomycin
Generic name (nonproprietary): mitomycin
Active ingredients: Mitomycin — 40 mg/80mL
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 216648
Marketing start: Nov 22, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 68083-502_5a0916d0-90cc-4ac2-82ba-e44138161853SPL ID 5a0916d0-90cc-4ac2-82ba-e44138161853SPL set ID 2528999b-9f09-4e64-89fc-1e3d69c2d0b6RxCUI 1740898UNII 50SG953SK6
Pharmacologic class: Alkylating Drug

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

N468083050201 followed by a unit qualifier and the quantity

Package 68083-0502-01. 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.