palonosetron hydrochloride
- Product NDC
- 25021-783
- 11-digit product format
- 250210783
- Labeler code
- 25021
- Product ID
- 25021-783_5679dbc2-6417-4a54-a627-7f72293879ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- palonosetron hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA204289
- Marketing category
- ANDA
- Marketing start
- 2018-06-15
- Substance
- PALONOSETRON HYDROCHLORIDE
- Active strength
- .05 mg/mL
- 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 | .05 mg/mL |
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 |
|---|
| 25021-783-05 | palonosetron hydrochloride | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 5 |
| 25021-783-05 | palonosetron hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-783 | PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210503_6e60d03d-eae6-4924-a507-e77ea077c1ab.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 |
|---|
| 25021-783-05 | 25021078305 | 1 VIAL in 1 CARTON (25021-783-05) / 5 mL in 1 VIAL | 1 vial | 2018-06-15 | 0000-00-00 | No | No | Current |