Mitomycin
- Product NDC
- 0143-9280
- 11-digit product format
- 001439280
- Labeler code
- 0143
- Product ID
- 0143-9280_643836ac-d4dc-426c-96fa-44ef273198bc
- 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
- 1999-09-01
- 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
- Mitomycin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MITOMYCIN | 40 mg/80mL |
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 |
|---|
| 0143-9280-01 | Mitomycin | 80 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 80 | | 3 |
| 0143-9280-01 | Mitomycin | 1 in 1 BOX, UNIT-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9280 | MITOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230516_5917f7a7-cd20-407b-8dda-9fd58c5f47a6.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 |
|---|
| 0143-9280-01 | 00143928001 | 1 VIAL in 1 BOX, UNIT-DOSE (0143-9280-01) / 80 mL in 1 VIAL | 1 vial | 1999-09-01 | 0000-00-00 | No | No | Current |