Mesna
- Product NDC
- 68083-161
- 11-digit product format
- 680830161
- Labeler code
- 68083
- Product ID
- 68083-161_b61d560c-02fd-4ae7-a6f7-fa7edb0a0d3f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mesna Injection
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA206992
- Marketing category
- ANDA
- Marketing start
- 2017-12-20
- Substance
- MESNA
- Active strength
- 100 mg/mL
- Pharmacologic classes
- Cytoprotective Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mesna
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MESNA | 100 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | NR7O1405Q9 |
| Rxcui | 204870 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-161-01 | Mesna | 1 in 1 CARTON | SOLUTION | 1 | | 10 |
| 68083-161-01 | Mesna | 10 mL in 1 VIAL, MULTI-DOSE | SOLUTION | 10 | | 10 |
| 68083-161-10 | Mesna | 10 mL in 1 VIAL, MULTI-DOSE | SOLUTION | 10 | | 10 |
| 68083-161-10 | Mesna | 10 in 1 CARTON | SOLUTION | 10 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-161 | MESNA (MESNA INJECTION) SOLUTION [GLAND PHARMA LIMITED] | 10 | Current NDC, Legacy NDC, 4 package rows | 20221008_a7af968c-05cf-4438-94ba-96a2baf9c367.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68083-161-01 | 68083016101 | 1 VIAL, MULTI-DOSE in 1 CARTON (68083-161-01) / 10 mL in 1 VIAL, MULTI-DOSE | 2017-12-20 | 0000-00-00 | No | No | Current |
| 68083-161-10 | 68083016110 | 10 VIAL, MULTI-DOSE in 1 CARTON (68083-161-10) / 10 mL in 1 VIAL, MULTI-DOSE | 2017-12-20 | 0000-00-00 | No | No | Current |