Palonosetron
- Product NDC
- 55111-694
- 11-digit product format
- 551110694
- Labeler code
- 55111
- Product ID
- 55111-694_7b1217ad-b626-0b2b-88d8-ae44fa91dbbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Palonosetron
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Dr.Reddy's Laboratories Limited
- Application
- ANDA201533
- Marketing category
- ANDA
- Marketing start
- 2018-03-23
- 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
- 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 | 1728050, 1728055 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-694-07 | Palonosetron | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 11 |
| 55111-694-07 | Palonosetron | 5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 5 | | 11 |
| 55111-694-15 | Palonosetron | 1.5 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 1.5 | | 11 |
| 55111-694-19 | Palonosetron | 5 in 1 CARTON | INJECTION, SOLUTION | 5 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-694 | PALONOSETRON INJECTION, SOLUTION [DR.REDDY'S LABORATORIES LIMITED] | 11 | Current NDC, Legacy NDC, 4 package rows | 20201218_991b8452-852c-c55c-7b1b-e97c4964777a.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 |
|---|
| 55111-694-07 | 55111069407 | 1 VIAL, SINGLE-USE in 1 CARTON (55111-694-07) / 5 mL in 1 VIAL, SINGLE-USE | | 2018-03-23 | 0000-00-00 | No | No | Current |
| 55111-694-15 | 55111069415 | 1.5 mL in 1 VIAL, SINGLE-USE | 1.5 ml | | | | | Historical |
| 55111-694-19 | 55111069419 | 5 VIAL, SINGLE-USE in 1 CARTON (55111-694-19) / 1.5 mL in 1 VIAL, SINGLE-USE (55111-694-15) | | 2018-03-23 | 0000-00-00 | No | No | Current |