Prescription drug · ANDA

Mitomycin NDC 68001-617

Mitomycin 40 mg/80mL · Injection, Powder, Lyophilized, For solution · Intravenous · BluePoint Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)68001-617Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0617Add 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
68001-617-7968001061779680010617791 VIAL, SINGLE-DOSE in 1 CARTON (68001-617-79) / 80 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 11, 2024

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
BluePoint LaboratoriesNDC labeler code 68001
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 68001-617_2094e27c-5df6-5cb8-e063-6294a90ae690SPL ID 2094e27c-5df6-5cb8-e063-6294a90ae690SPL set ID 57129df7-d6b1-419e-90ec-54f9b5182e7cRxCUI 1740894, 1740898, 1740900UNII 50SG953SK6UPC 0368001617796, 0368001616775, 0368001615365
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

N468001061779 followed by a unit qualifier and the quantity

Package 68001-0617-79. 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 68001-617

What is NDC 68001-617?
68001-617 is the product NDC for Mitomycin, Mitomycin 40 mg/80mL injection, powder, lyophilized, for solution, listed with the FDA by BluePoint Laboratories. 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?
BluePoint Laboratories, NDC labeler code 68001. 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 5 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-61568001-0615-36
MitomycinMitomycin 20 mg/40mLInjection, Powder, Lyophilized, For solutionIntravenousBluePoint Laboratories68001-61668001-0616-77
MitomycinMitomycin 5 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-45055150-0450-01
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 5 mg/10mLInjection, Powder, Lyophilized, For solutionIntravenousEugia US LLC55150-450
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

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