Prescription drug · ANDA
Mitomycin NDC 68001-389
Mitomycin 5 mg/10mL · Injection, Powder, Lyophilized, For solution · Intravenous · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-389-36 | 68001038936 | 1 VIAL in 1 CARTON (68001-389-36) / 10 mL in 1 VIAL (68001-389-28)Marketed from May 14, 2019 |
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
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064144
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 68001-389_c455e123-6115-d234-e053-2995a90a2e93SPL ID c455e123-6115-d234-e053-2995a90a2e93SPL set ID aad9a9a0-7204-452a-8b9b-6d625c4ee021RxCUI 1740894, 1740898, 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
N468001038936followed by a unit qualifier and the quantityPackage 68001-0389-36. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 064144
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 |
|---|---|---|---|---|
| Mutamycinmitomycin | Mitomycin 5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord BioPharma Inc. | 69448-001 |
| Mutamycinmitomycin | Mitomycin 40 mg/80mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord BioPharma Inc. | 69448-003 |
| Mitomycin | Mitomycin 20 mg/40mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord Healthcare, Inc. | 16729-108 |
| Mitomycin | Mitomycin 5 mg/10mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord Healthcare, Inc. | 16729-115 |
| Mitomycin | Mitomycin 40 mg/80mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord Healthcare, Inc. | 16729-116 |
| Mitomycin | Mitomycin 40 mg/80mL | Injection, Powder, Lyophilized, For solutionIntravenous | BluePoint Laboratories | 68001-391 |
| Mitomycin | Mitomycin 20 mg/40mL | Injection, Powder, Lyophilized, For solutionIntravenous | BluePoint Laboratories | 68001-390 |