Prescription drug · ANDA
Mitomycin NDC 0143-9279
Mitomycin 20 mg/40mL · Injection, Powder, Lyophilized, For solution · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9279-01 | 00143927901 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9279-01) / 40 mL in 1 VIALMarketed from May 1, 1996 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 20 mg/40mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064117
- Marketing start
- Listing expires
- Other FDA classes
- Alkylating Activity (Mechanism)
- Identifiers
- Product ID 0143-9279_a5fb5de7-410a-4bf1-ab0b-2e552e21760bSPL ID a5fb5de7-410a-4bf1-ab0b-2e552e21760bSPL set ID 5917f7a7-cd20-407b-8dda-9fd58c5f47a6RxCUI 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
N400143927901followed by a unit qualifier and the quantityPackage 00143-9279-01. 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.
Other NDCs under ANDA 064117
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 | Hikma Pharmaceuticals USA Inc. | 0143-9280 |
| Mitomycin | Mitomycin 20 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9135 |
| Mitomycin | Mitomycin 40 mg/1 | Injection, Powder, Lyophilized, For solutionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9136 |