Palonosetron
- Product NDC
- 67184-0514
- 11-digit product format
- 671840514
- Labeler code
- 67184
- Product ID
- 67184-0514_abeff9bd-6829-445c-93b8-3d9217993b9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Palonosetron Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA205648
- Marketing category
- ANDA
- Marketing start
- 2018-09-19
- 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
- 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 | 1728050, 1728055 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67184-0514-1 | Palonosetron | 1 in 1 CARTON | INJECTION | 1 | | 3 |
| 67184-0514-1 | Palonosetron | 5 mL in 1 VIAL | INJECTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0514 | PALONOSETRON (PALONOSETRON HYDROCHLORIDE) INJECTION [QILU PHARMACEUTICAL CO., LTD.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20211020_633abdc2-a942-4eb2-a0f8-f9f4e727211e.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 |
|---|
| 67184-0514-1 | 67184051401 | 1 VIAL in 1 CARTON (67184-0514-1) / 5 mL in 1 VIAL | 1 vial | 2018-09-19 | 0000-00-00 | No | No | Current |