Mitomycin
- Product NDC
- 0143-9136
- 11-digit product format
- 001439136
- Labeler code
- 0143
- Product ID
- 0143-9136_967161c6-2423-4ce9-b386-0a4855b1cb75
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mitomycin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA064117
- Marketing category
- ANDA
- Marketing start
- 2022-10-01
- Substance
- MITOMYCIN
- Active strength
- 40 mg/1
- 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 | 40 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 50SG953SK6 |
| Rxcui | 1740898, 1740900 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9136-01 | Mitomycin | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 0143-9136-01 | Mitomycin | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9136 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20221001_fde1e4e9-fc67-4e84-aa31-0cf0e73e19a8.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 |
|---|
| 0143-9136-01 | 00143913601 | 1 VIAL in 1 BOX (0143-9136-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2022-10-01 | 0000-00-00 | No | No | Current |