Mitomycin
- Product NDC
- 67457-997
- 11-digit product format
- 674570997
- Labeler code
- 67457
- Product ID
- 67457-997_f5c057dc-8eb5-4c53-99aa-3c5a207dff14
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA203386
- Marketing category
- ANDA
- Marketing start
- 2020-08-28
- Marketing end
- 0000-00-00
- Substance
- MITOMYCIN
- Active strength
- 40 mg/80mL
- Pharmacologic classes
- Alkylating Activity [MoA],Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-997-40 | 67457099740 | 1 VIAL in 1 CARTON (67457-997-40) > 80 mL in 1 VIAL | 1 vial | 2020-08-28 | 0000-00-00 | No | No | Current |