Mitomycin
- Product NDC
- 16729-248
- 11-digit product format
- 167290248
- Labeler code
- 16729
- Product ID
- 16729-248_aef290ae-6765-8c1e-e053-2a95a90a689a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc
- Application
- ANDA064144
- Marketing category
- ANDA
- Marketing start
- 2013-05-03
- Marketing end
- 0000-00-00
- Substance
- MITOMYCIN
- Active strength
- 40 mg/10mL
- 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 |
|---|
| 16729-248-38 | 16729024838 | 1 VIAL in 1 CARTON (16729-248-38) > 10 mL in 1 VIAL | 1 vial | 2013-05-03 | 0000-00-00 | No | No | Current |