What is NDC 68083-484?

68083-484 is the product NDC for Mitomycin, Mitomycin 20 mg/40mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mitomycin?

29 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mitomycin NDC 68083-484 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-484Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0484Add 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
68083-484-01	6808304840168083048401	1 VIAL in 1 CARTON (68083-484-01) / 40 mL in 1 VIALMarketed from Oct 20, 2021

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 — 20 mg/40mL
Dosage form: Injection, Powder, Lyophilized, For solution
Route: Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215687
Marketing start: Oct 20, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Alkylating Activity (Mechanism)
Identifiers: Product ID 68083-484_64496224-9cec-48bb-a750-db192dd7780cSPL ID 64496224-9cec-48bb-a750-db192dd7780cSPL set ID 650d3024-b9a9-4018-8115-0951acfe3145RxCUI 1740894, 1740900UNII 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

N468083048401 followed by a unit qualifier and the quantity

Package 68083-0484-01. 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 Oct 22, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Mitomycin for Injection, USP is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-484

What is NDC 68083-484?: 68083-484 is the product NDC for Mitomycin, Mitomycin 20 mg/40mL injection, powder, lyophilized, for solution, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mitomycin.
What is the active ingredient?: Mitomycin.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mitomycin?: 29 other product NDCs are listed under this name. See all Mitomycin 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 Mitomycin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Mitomycin	Mitomycin 40 mg/80mL	Injection, Powder, Lyophilized, For solutionIntravenous	BluePoint Laboratories	68001-617	68001-0617-79
Mitomycin	Mitomycin 5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	BluePoint Laboratories	68001-615	68001-0615-36
Mitomycin	Mitomycin 20 mg/40mL	Injection, Powder, Lyophilized, For solutionIntravenous	BluePoint Laboratories	68001-616	68001-0616-77
Mitomycin	Mitomycin 5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-450	55150-0450-01
Mitomycin	Mitomycin 20 mg/40mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-451	55150-0451-01
Mitomycin	Mitomycin 40 mg/80mL	Injection, Powder, Lyophilized, For solutionIntravenous	Eugia US LLC	55150-452	55150-0452-01
Mitomycin	Mitomycin 5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-250	25021-0250-20
Mitomycin	Mitomycin 20 mg/40mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-251	25021-0251-50
Mitomycin	Mitomycin 40 mg/80mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-252	25021-0252-51
Mitomycin	Mitomycin 5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	65219-564	65219-0564-20

All 30 Mitomycin NDCs

Other NDCs under ANDA 215687

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

FDA NDC Directory listings under ANDA 215687
Product	Strength	Form · route	Labeler	Product NDC
Mitomycin	Mitomycin 5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-250
Mitomycin	Mitomycin 20 mg/40mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-251
Mitomycin	Mitomycin 5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	65219-564
Mitomycin	Mitomycin 20 mg/40mL	Injection, Powder, Lyophilized, For solutionIntravenous	Fresenius Kabi USA, LLC	65219-566
Mitomycin	Mitomycin 5 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	Gland Pharma Limited	68083-483