Mitomycin
- Product NDC
- 72162-2464
- 11-digit product format
- 721622464
- Labeler code
- 72162
- Product ID
- 72162-2464_5344ba2c-faed-481f-9230-722e9854fd2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Bryant Ranch Prepack
- 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 |
|---|
| 72162-2464-2 | Mitomycin | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 100 |
| 72162-2464-2 | Mitomycin | 10 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 10 | | 100 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-2464 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BRYANT RANCH PREPACK] | 100 | Current NDC, 2 package rows | 20250309_799a06b1-7697-42a3-b31a-c9d621b34f6f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2464-2 | 72162246402 | 1 VIAL in 1 CARTON (72162-2464-2) / 10 mL in 1 VIAL | 1 vial | 2025-03-06 | No | No | Current |