Prescription drug · ANDA
Mitomycin NDC 65219-568
Mitomycin 40 mg/80mL · Injection, Powder, Lyophilized, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-568-00 | 6521905680065219056800 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-568-00) / 80 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 15, 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 — 40 mg/80mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216648
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 65219-568_c8893d3b-e9e0-4ab1-8c6d-376a7f1037bcSPL ID c8893d3b-e9e0-4ab1-8c6d-376a7f1037bcSPL set ID bc937e3d-7167-49a5-b6b1-004b0f89d8c4RxCUI 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.
- NDC on a medical claim
N465219056800followed by a unit qualifier and the quantityPackage 65219-0568-00. 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 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.
About NDC 65219-568
- What is NDC 65219-568?
- 65219-568 is the product NDC for Mitomycin, Mitomycin 40 mg/80mL injection, powder, lyophilized, for solution, listed with the FDA by Fresenius Kabi USA, 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?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. 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.
Related NDCs: other Mitomycin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 216648
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Mitomycin | Mitomycin 40 mg/80mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-252 |
| Mitomycin | Mitomycin 40 mg/80mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-502 |