MITOMYCIN
- Product NDC
- 68083-484
- 11-digit product format
- 680830484
- Labeler code
- 68083
- Product ID
- 68083-484_64496224-9cec-48bb-a750-db192dd7780c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MITOMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA215687
- Marketing category
- ANDA
- Marketing start
- 2021-10-20
- 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, 1740900 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-484-01 | MITOMYCIN | 40 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 40 | | 3 |
| 68083-484-01 | 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 |
|---|
| 68083-484 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211027_650d3024-b9a9-4018-8115-0951acfe3145.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-484-01 | 68083048401 | 1 VIAL in 1 CARTON (68083-484-01) / 40 mL in 1 VIAL | 1 vial | 2021-10-20 | 0000-00-00 | No | No | Current |