Mitomycin
- Product NDC
- 72819-152
- 11-digit product format
- 728190152
- Labeler code
- 72819
- Product ID
- 72819-152_05e37cd7-f0c4-3bde-e063-6294a90a2acf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Archis Pharma LLC
- 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 |
|---|
| 72819-152-05 | Mitomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 72819-152-05 | Mitomycin | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 2 |
| 72819-152-95 | Mitomycin | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 2 |
| 72819-152-95 | Mitomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72819-152 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ARCHIS PHARMA LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230606_2ecd0f9c-0980-4ac5-bd1b-0a0aee799b6f.zip |
| 72819-152 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ARCHIS PHARMA LLC] | 2 | Current NDC, Legacy NDC, 2 package rows | 20230922_cef5026c-8bc3-4428-a178-6effff4dcb3f.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 |
|---|
| 72819-152-05 | 72819015205 | 1 VIAL in 1 CARTON (72819-152-05) / 10 mL in 1 VIAL | 1 vial | 2022-04-25 | | No | No | Historical |
| 72819-152-95 | 72819015295 | 1 VIAL in 1 CARTON (72819-152-95) / 10 mL in 1 VIAL | 1 vial | 2022-03-11 | 0000-00-00 | No | No | Current |