Palonosetron
- Product NDC
- 63323-942
- 11-digit product format
- 633230942
- Labeler code
- 63323
- Product ID
- 63323-942_61109020-f621-4aba-9578-74f156bfc5f0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Palonosetron
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- NDA208109
- Marketing category
- NDA
- Marketing start
- 2017-06-01
- Marketing end
- 0000-00-00
- Substance
- PALONOSETRON HYDROCHLORIDE
- Active strength
- 0 mg/5mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 63323-942 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 63323-942 | 63323-942-05 | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 63323-942 | 63323-942-90 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| N208109-001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) | SOLUTION / INTRAVENOUS | | RLD | 2017-11-21 |