Palonosetron Hydrochloride
- Product NDC
- 55150-186
- 11-digit product format
- 551500186
- Labeler code
- 55150
- Product ID
- 55150-186_2cea6e62-677a-40a9-9e8b-84b2e95263cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Palonosetron Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA204702
- Marketing category
- ANDA
- Marketing start
- 2018-11-06
- Substance
- PALONOSETRON HYDROCHLORIDE
- Active strength
- .25 mg/5mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Palonosetron Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALONOSETRON HYDROCHLORIDE | .25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 23310D4I19 |
| Rxcui | 1728055 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-186-05 | Palonosetron Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
| 55150-186-05 | Palonosetron Hydrochloride | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-186 | PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241122_42e2d437-0712-4e9c-9c2a-00093c406d62.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 |
|---|
| 55150-186-05 | 55150018605 | 1 VIAL, SINGLE-USE in 1 CARTON (55150-186-05) / 5 mL in 1 VIAL, SINGLE-USE | 2018-11-06 | 0000-00-00 | No | No | Current |