Prescription drug · ANDA

Mitomycin NDC 55150-450

Mitomycin 5 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Eugia US LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55150-450Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55150-0450Add 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
55150-450-0155150045001551500450011 VIAL, SINGLE-DOSE in 1 CARTON (55150-450-01) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Oct 30, 2023

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 — 5 mg/10mL
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intravenous
Labeler
Eugia US LLCNDC labeler code 55150
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216732
Marketing start
Listing expires
Other FDA classes
Alkylating Activity (Mechanism)
Identifiers
Product ID 55150-450_f5a010cf-5954-4e6d-acfa-fb414efdf471SPL ID f5a010cf-5954-4e6d-acfa-fb414efdf471SPL set ID f5a010cf-5954-4e6d-acfa-fb414efdf471RxCUI 1740894, 1740898, 1740900UNII 50SG953SK6UPC 0355150451012
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

N455150045001 followed by a unit qualifier and the quantity

Package 55150-0450-01. 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)

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 55150-450

What is NDC 55150-450?
55150-450 is the product NDC for Mitomycin, Mitomycin 5 mg/10mL injection, powder, lyophilized, for solution, listed with the FDA by Eugia US LLC. 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?
Eugia US LLC, NDC labeler code 55150. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MitomycinMitomycin 40 mg/80mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-61768001-0617-79
MitomycinMitomycin 5 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-61568001-0615-36
MitomycinMitomycin 20 mg/40mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-61668001-0616-77
MitomycinMitomycin 20 mg/40mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-45155150-0451-01
MitomycinMitomycin 40 mg/80mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-45255150-0452-01
MitomycinMitomycin 5 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousSagent Pharmaceuticals25021-25025021-0250-20
MitomycinMitomycin 20 mg/40mLInjection, Powder, Lyophilized, For solutionIntravenousSagent Pharmaceuticals25021-25125021-0251-50
MitomycinMitomycin 40 mg/80mLInjection, Powder, Lyophilized, For solutionIntravenousSagent Pharmaceuticals25021-25225021-0252-51
MitomycinMitomycin 5 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousFresenius Kabi USA, LLC65219-56465219-0564-20
MitomycinMitomycin 20 mg/40mLInjection, Powder, Lyophilized, For solutionIntravenousFresenius Kabi USA, LLC65219-56665219-0566-20

All 30 Mitomycin NDCs

Other NDCs under ANDA 216732

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

FDA NDC Directory listings under ANDA 216732
ProductStrengthForm · routeLabelerProduct NDC
MitomycinMitomycin 20 mg/40mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-451
MitomycinMitomycin 40 mg/80mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-452
MitomycinMitomycin 5 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-615
MitomycinMitomycin 20 mg/40mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-616
MitomycinMitomycin 40 mg/80mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-617

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