Palonosetron Hydrochloride
- Product NDC
- 67457-317
- 11-digit product format
- 674570317
- Labeler code
- 67457
- Product ID
- 67457-317_4fbe587d-ddb7-42fd-aad9-e749689d2276
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Palonosetron Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA206416
- Marketing category
- ANDA
- Marketing start
- 2018-09-20
- 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 |
|---|
| 67457-317-25 | Palonosetron Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 3 |
| 67457-317-25 | Palonosetron Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-317 | PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20200807_0a781796-bb74-4c5f-8d26-9ce520b818f7.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 |
|---|
| 67457-317-25 | 67457031725 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25) / 5 mL in 1 VIAL, SINGLE-DOSE | 2018-09-20 | 0000-00-00 | No | No | Current |