What is NDC 55111-694?

55111-694 is the product NDC for Palonosetron, Palonosetron hydrochloride .05 mg/mL injection, solution, listed with the FDA by Dr.Reddy's Laboratories Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Dr.Reddy's Laboratories Limited, NDC labeler code 55111. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Palonosetron NDC 55111-694 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-694Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0694Add 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
55111-694-07	5511106940755111069407	1 VIAL, SINGLE-USE in 1 CARTON (55111-694-07) / 5 mL in 1 VIAL, SINGLE-USEMarketed from Mar 23, 2018
55111-694-19	5511106941955111069419	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
Labeler: Dr.Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201533
Marketing start: Mar 23, 2018
Listing expires: Dec 31, 2026
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.

How CPT relates to drug billing

NDC on a medical claim

N455111069407 followed by a unit qualifier and the quantity

Package 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 Aug 30, 2020.

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.

Full label on DailyMed (opens in a new tab)

About NDC 55111-694

What is NDC 55111-694?: 55111-694 is the product NDC for Palonosetron, Palonosetron hydrochloride .05 mg/mL injection, solution, listed with the FDA by Dr.Reddy's Laboratories Limited. It has 2 package NDCs, 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?: Dr.Reddy's Laboratories Limited, NDC labeler code 55111. 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.

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

Other Palonosetron NDCs
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	NorthStar Rx LLC	16714-834	16714-0834-01

Other NDCs under ANDA 201533

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 201533
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