MITOMYCIN
- Product NDC
- 55150-451
- 11-digit product format
- 551500451
- Labeler code
- 55150
- Product ID
- 55150-451_f5a010cf-5954-4e6d-acfa-fb414efdf471
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MITOMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA216732
- Marketing category
- ANDA
- Marketing start
- 2023-10-30
- Substance
- MITOMYCIN
- Active strength
- 20 mg/40mL
- 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 | 20 mg/40mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50SG953SK6 |
| Rxcui | 1740894, 1740898, 1740900 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-451-01 | MITOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 55150-451-01 | MITOMYCIN | 40 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 40 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-451 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 1 | Current NDC, 2 package rows | 20231101_f5a010cf-5954-4e6d-acfa-fb414efdf471.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-451-01 | 55150045101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-451-01) / 40 mL in 1 VIAL, SINGLE-DOSE | 2023-10-30 | No | No | Current |