Prescription drug · ANDA
Palonosetron (Palonosetron hydrochloride) NDC 67184-0515
Palonosetron hydrochloride .075 mg/1.5mL · Injection · Intravenous · Qilu Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67184-0515-2 | 6718405150267184051502 | 5 VIAL in 1 CARTON (67184-0515-2) / 1.5 mL in 1 VIAL (67184-0515-1)Marketed from Sep 19, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride
- Active ingredients
- Palonosetron hydrochloride — .075 mg/1.5mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Qilu Pharmaceutical Co., Ltd.NDC labeler code 67184
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205648
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 67184-0515_abeff9bd-6829-445c-93b8-3d9217993b9cSPL ID abeff9bd-6829-445c-93b8-3d9217993b9cSPL set ID 633abdc2-a942-4eb2-a0f8-f9f4e727211eRxCUI 1728050, 1728055UNII 23310D4I19UPC 0367184051410
- 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
N467184051502followed by a unit qualifier and the quantityPackage 67184-0515-02. 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 67184-0515
- What is NDC 67184-0515?
- 67184-0515 is the product NDC for Palonosetron (palonosetron hydrochloride), Palonosetron hydrochloride .075 mg/1.5mL injection, listed with the FDA by Qilu Pharmaceutical Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Palonosetron (Palonosetron Hydrochloride).
- What is the active ingredient?
- Palonosetron hydrochloride.
- Who is the labeler?
- Qilu Pharmaceutical Co., Ltd., NDC labeler code 67184. 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 |
| Palonosetron | Palonosetron hydrochloride .05 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-355 | 68001-0355-25 |
| Palonosetron | Palonosetron hydrochloride .05 mg/mL | Injection, SolutionIntravenous | NorthStar Rx LLC | 16714-834 | 16714-0834-01 |
| Palonosetron | Palonosetron hydrochloride .05 mg/mL | Injection, SolutionIntravenous | Dr.Reddy's Laboratories Limited | 55111-694 | 55111-0694-0755111-0694-19 |
Other NDCs under ANDA 205648
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 |
|---|---|---|---|---|
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .25 mg/5mL | InjectionIntravenous | Apotex Corp. | 60505-6193 |
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .25 mg/5mL | InjectionIntravenous | Apotex Corp. | 60505-6439 |
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .25 mg/5mL | InjectionIntravenous | Qilu Pharmaceutical Co., Ltd. | 67184-0514 |
| Palonosetronpalonosetron hydrochloride | Palonosetron hydrochloride .25 mg/5mL | InjectionIntravenous | BLuePoint Laboratories | 68001-708 |