Mitomycin
- Product NDC
- 16729-108
- 11-digit product format
- 167290108
- Labeler code
- 16729
- Product ID
- 16729-108_3363b2a9-5d4f-d921-e063-6294a90a7fbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA064144
- Marketing category
- ANDA
- Marketing start
- 2009-06-10
- 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, 1740898, 1740900 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-108-11 | Mitomycin | 1 in 1 BOX, UNIT-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 10 |
| 16729-108-11 | Mitomycin | 40 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 40 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MITOMYCIN | ACTIVE INGREDIENT | 50SG953SK6 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC] | 4 | |
| MITOMYCIN | ACTIVE MOIETY | 50SG953SK6 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC] | 4 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE INC] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-108 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250515_ff676355-313d-4575-8f2f-e4a1e9527477.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 |
|---|
| 16729-108-11 | 16729010811 | 1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) / 40 mL in 1 VIAL | 1 vial | 2009-06-10 | 0000-00-00 | No | No | Current |