Prescription drug · ANDA
Palonosetron NDC 16714-834
Palonosetron hydrochloride .05 mg/mL · Injection, Solution · Intravenous · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-834-01 | 1671408340116714083401 | 1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) / 5 mL in 1 VIAL, SINGLE-USEMarketed from May 29, 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
- Labeler
- NorthStar Rx LLCNDC labeler code 16714
- 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 16714-834_8d32d892-2cbb-f22e-0084-b405875974afSPL ID 8d32d892-2cbb-f22e-0084-b405875974afSPL set ID 689c953c-2120-2546-67a4-22bb34ba3330RxCUI 1728055UNII 23310D4I19UPC 0316714834016
- 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
N416714083401followed by a unit qualifier and the quantityPackage 16714-0834-01. 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.
About NDC 16714-834
- What is NDC 16714-834?
- 16714-834 is the product NDC for Palonosetron, Palonosetron hydrochloride .05 mg/mL injection, solution, listed with the FDA by NorthStar Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Palonosetron.
- What is the active ingredient?
- Palonosetron hydrochloride.
- Who is the labeler?
- NorthStar Rx LLC, NDC labeler code 16714. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Palonosetron?
- 8 other product NDCs are listed under this name. See all Palonosetron NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Palonosetron products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .25 mg/5mL | InjectionIntravenous | BLuePoint Laboratories | 68001-708 | 68001-0708-25 |
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .25 mg/5mL | InjectionIntravenous | Apotex Corp. | 60505-6439 | 60505-6439-01 |
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .25 mg/5mL | InjectionIntravenous | Apotex Corp. | 60505-6193 | 60505-6193-0160505-6193-04 |
| Palonosetron | Palonosetron hydrochloride .25 mg/5mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-673 | 63323-0673-89 |
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .25 mg/5mL | InjectionIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0514 | 67184-0514-01 |
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .075 mg/1.5mL | InjectionIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0515 | 67184-0515-02 |
| Palonosetron | Palonosetron hydrochloride .05 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-355 | 68001-0355-25 |
| Palonosetron | Palonosetron hydrochloride .05 mg/mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Limited | 55111-694 | 55111-0694-0755111-0694-19 |
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 | Dr.Reddy's Laboratories Limited | 55111-694 |
| Palonosetron | Palonosetron hydrochloride .05 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-355 |