MITOMYCIN
- Product NDC
- 65219-564
- 11-digit product format
- 652190564
- Labeler code
- 65219
- Product ID
- 65219-564_204bc630-60a8-46e7-8dc7-aa781b46ff2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MITOMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA215687
- Marketing category
- ANDA
- Marketing start
- 2023-01-15
- Substance
- MITOMYCIN
- Active strength
- 5 mg/10mL
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MITOMYCIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MITOMYCIN | 5 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50SG953SK6 |
| Rxcui | 1740894, 1740900 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65219-564-20 | MITOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 65219-564-20 | MITOMYCIN | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-564 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 2 package rows | 20230115_6a4fbc96-e35d-41c2-91fc-4b48220bdba2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-564-20 | 65219056420 | 1 VIAL in 1 CARTON (65219-564-20) / 10 mL in 1 VIAL | 1 vial | 2023-01-15 | No | No | Current |