MITOMYCIN
- Product NDC
- 71288-138
- 11-digit product format
- 712880138
- Labeler code
- 71288
- Product ID
- 71288-138_a78f4900-61e4-4e22-bfcb-6b5210c94c57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MITOMYCIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA214505
- Marketing category
- ANDA
- Marketing start
- 2022-09-08
- 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 |
|---|
| 71288-138-50 | MITOMYCIN | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 4 |
| 71288-138-50 | MITOMYCIN | 40 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 40 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-138 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220914_9dd0e3f2-0938-4c57-8d09-040b5405b44f.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 |
|---|
| 71288-138-50 | 71288013850 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-138-50) / 40 mL in 1 VIAL, SINGLE-DOSE | 2022-09-08 | 0000-00-00 | No | No | Current |