Prescription drug · ANDA
Palonosetron NDC 55111-694
Palonosetron hydrochloride .05 mg/mL · Injection, Solution · Intravenous · Dr.Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-694-07 | 55111069407 | 1 VIAL, SINGLE-USE in 1 CARTON (55111-694-07) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Mar 23, 2018 | |
| 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)Marketed from Mar 23, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Palonosetron
- Generic name (nonproprietary)
- palonosetron
- Active ingredients
- Palonosetron hydrochloride — .05 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201533
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 55111-694_7b1217ad-b626-0b2b-88d8-ae44fa91dbbdSPL ID 7b1217ad-b626-0b2b-88d8-ae44fa91dbbdSPL set ID 991b8452-852c-c55c-7b1b-e97c4964777aRxCUI 1728050, 1728055UNII 23310D4I19
- Pharmacologic class
- Serotonin-3 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N455111069407followed by a unit qualifier and the quantityPackage 55111-0694-07. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Palonosetron hydrochloride injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in: Adults for prevention of : acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). ( 1 ) acute nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC). ( 1 ) postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1 ) Pediatric patients aged 1 month to less than 17 years for prevention of : acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy,…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201533
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Palonosetron | Palonosetron hydrochloride .05 mg/mL | Injection, SolutionIntravenous | NorthStar Rx LLC | 16714-834 |
| Palonosetron | Palonosetron hydrochloride .05 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-355 |