Palonosetron Hydrochloride
- Product NDC
- 0143-9513
- 11-digit product format
- 001439513
- Labeler code
- 0143
- Product ID
- 0143-9513_7dc05b1a-344a-410b-a7b3-171727713cf1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Palonosetron Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- West-Ward Pharmaceuticals Corp
- Application
- NDA207963
- Marketing category
- NDA
- Marketing start
- 2017-09-01
- Marketing end
- 0000-00-00
- Substance
- PALONOSETRON HYDROCHLORIDE
- Active strength
- 0 mg/2mL
- Pharmacologic classes
- Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 0143-9513 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 0143-9513 | 0143-9513-01 | 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 |
|---|
| N207963-001 | PALONOSETRON HYDROCHLORIDE | PALONOSETRON HYDROCHLORIDE | EQ 0.25MG BASE/2ML (EQ 0.125MG BASE/ML) | SOLUTION / INTRAVENOUS | | | 2016-08-22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9513 | PALONOSETRON HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICALS CORP] | 3 | Legacy NDC | 20181213_bb20ba9b-aa8c-4b24-8124-aff0cb6c956b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9513-01 | 00143951301 | 2 mL in 1 VIAL (0143-9513-01) | 2 ml | 2017-09-01 | 0000-00-00 | No | No | Current |