What is NDC 69097-927?

69097-927 is the product NDC for palonosetron hydrochloride, Palonosetron hydrochloride .25 mg/5mL injection, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 hydrochloride?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

palonosetron hydrochloride NDC 69097-927

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-927Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0927Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
69097-927-35	6909709273569097092735	1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIALMarketed 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 hydrochloride
Generic name (nonproprietary): palonosetron hydrochloride
Active ingredients: Palonosetron hydrochloride — .25 mg/5mL
Dosage form: Injection
Route: Intravenous
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021372
Marketing start: Mar 23, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 69097-927_04460041-adec-463b-ba9d-6a12038ab672SPL ID 04460041-adec-463b-ba9d-6a12038ab672SPL set ID 37e7ef89-fd77-44e0-9271-ae91f8822603RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N469097092735 followed by a unit qualifier and the quantity

Package 69097-0927-35. 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 Jan 13, 2022.

Indications (excerpt from the label)

Palonosetron Hydrochloride Injection is a serotonin-3 (5-HT 3 ) receptor antagonist indicated in adults for: Moderately emetogenic cancer chemotherapy - prevention of acute and delayed nausea and vomiting associated with initial and repeat courses ( 1 .1) Highly emetogenic cancer chemotherapy - prevention of acute nausea and vomiting associated with initial and repeat courses ( 1.1 ) Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated ( 1.3 ) Palonosetron Hydrochloride Injection is indicated in pediatric patients aged 1 month to less than 17 years for: Prevention of acute nausea and vomiting associate…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-927

What is NDC 69097-927?: 69097-927 is the product NDC for palonosetron hydrochloride, Palonosetron hydrochloride .25 mg/5mL injection, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: palonosetron hydrochloride.
What is the active ingredient?: Palonosetron hydrochloride.
Who is the labeler?: Cipla USA Inc., NDC labeler code 69097. 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 hydrochloride?: 7 other product NDCs are listed under this name. See all palonosetron hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other palonosetron hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-409	71288-0409-05
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	InjectionIntravenous	Baxter Healthcare Corporation	36000-326	36000-0326-02
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Eugia US LLC	55150-186	55150-0186-05
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Mylan Institutional LLC	67457-317	67457-0317-25
palonosetron hydrochloride	Palonosetron hydrochloride .05 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-783	25021-0783-05
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Teva Parenteral Medicines, Inc.	0703-4094	00703-4094-01
Palonosetron Hydrochloride	Palonosetron hydrochloride .25 mg/5mL	Injection, SolutionIntravenous	Sandoz Inc	0781-3312	00781-3312-7500781-3312-95