Valrubicin Intravesical Solution
- Product NDC
- 24201-101
- 11-digit product format
- 242010101
- Labeler code
- 24201
- Product ID
- 24201-101_f2385edd-45ba-4ce8-97a0-ac301d067536
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Valrubicin Intravesical Solution
- Dosage form
- SOLUTION, CONCENTRATE
- Route
- INTRAVESICAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA206430
- Marketing category
- ANDA
- Marketing start
- 2019-04-23
- Substance
- VALRUBICIN
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Valrubicin Intravesical Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VALRUBICIN | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2C6NUM6878 |
| Rxcui | 313567 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24201-101-04 | Valrubicin Intravesical Solution | 4 in 1 CARTON | SOLUTION, CONCENTRATE | 4 | | 2 |
| 24201-101-04 | Valrubicin Intravesical Solution | 5 mL in 1 VIAL | SOLUTION, CONCENTRATE | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24201-101 | VALRUBICIN INTRAVESICAL SOLUTION SOLUTION, CONCENTRATE [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221110_8739ae02-e4c5-0fa2-e053-2a91aa0a1b74.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 |
|---|
| 24201-101-04 | 24201010104 | 4 VIAL in 1 CARTON (24201-101-04) / 5 mL in 1 VIAL | 4 vial | 2019-04-23 | 0000-00-00 | No | No | Current |