MITOMYCIN
- Product NDC
- 68083-502
- 11-digit product format
- 680830502
- Labeler code
- 68083
- Product ID
- 68083-502_5a0916d0-90cc-4ac2-82ba-e44138161853
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MITOMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA216648
- Marketing category
- ANDA
- Marketing start
- 2022-11-22
- Substance
- MITOMYCIN
- Active strength
- 40 mg/80mL
- 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 | 40 mg/80mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50SG953SK6 |
| Rxcui | 1740898 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-502-01 | MITOMYCIN | 80 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 80 | | 3 |
| 68083-502-01 | MITOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-502 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221129_2528999b-9f09-4e64-89fc-1e3d69c2d0b6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-502-01 | 68083050201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-502-01) / 80 mL in 1 VIAL, SINGLE-DOSE | 2022-11-22 | 0000-00-00 | No | No | Current |