Mitomycin
- Product NDC
- 71335-2927
- 11-digit product format
- 713352927
- Labeler code
- 71335
- Product ID
- 71335-2927_fbb00883-4ca9-4396-bf6d-f5f1a136c08f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202670
- Marketing category
- ANDA
- Marketing start
- 2022-03-11
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-2927-1 | Mitomycin | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 100 |
| 71335-2927-1 | Mitomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 100 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2927-1 | 71335292701 | 1 VIAL in 1 CARTON (71335-2927-1) / 10 mL in 1 VIAL | 1 vial | 2025-11-11 | No | No | Current |