MUTAMYCIN
- Product NDC
- 69448-003
- 11-digit product format
- 694480003
- Labeler code
- 69448
- Product ID
- 69448-003_302614d9-cc10-737a-e063-6294a90a41c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord BioPharma Inc.
- Application
- ANDA064144
- Marketing category
- ANDA
- Marketing start
- 2017-07-25
- 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
- MUTAMYCIN
- 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 | 1740894, 1740898, 1740900, 1812480, 1812482, 1812484 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69448-003-38 | MUTAMYCIN | 1 in 1 BOX, UNIT-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 69448-003-38 | MUTAMYCIN | 80 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 80 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69448-003 | MUTAMYCIN (MITOMYCIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD BIOPHARMA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250315_cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e.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 |
|---|
| 69448-003-38 | 69448000338 | 1 VIAL in 1 BOX, UNIT-DOSE (69448-003-38) / 80 mL in 1 VIAL | 1 vial | 2017-07-25 | 0000-00-00 | No | No | Current |