Prescription drug · ANDA
Mitomycin NDC 25021-250
Mitomycin 5 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-250-20 | 25021025020 | 1 VIAL in 1 CARTON (25021-250-20) / 10 mL in 1 VIALMarketed from Jun 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 — 5 mg/10mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Sagent Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215687
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 25021-250_865914d0-b74e-4beb-a7d1-e31a82b75c05SPL ID 865914d0-b74e-4beb-a7d1-e31a82b75c05SPL set ID 10c41a58-c305-4240-80d2-caa070412648RxCUI 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.
- NDC on a medical claim
N425021025020followed by a unit qualifier and the quantityPackage 25021-0250-20. 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.
Other NDCs under ANDA 215687
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 20 mg/40mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-484 |
| Mitomycin | Mitomycin 5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Gland Pharma Limited | 68083-483 |
| 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 20 mg/40mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-251 |