What is NDC 80425-0228?

80425-0228 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ondansetron?

190 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ondansetron NDC 80425-0228 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0228Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0228Add 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
80425-0228-1	8042502280180425022801	3 BLISTER PACK in 1 CARTON (80425-0228-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 11, 2023

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): Ondansetron
Generic name (nonproprietary): ondansetron
Active ingredients: Ondansetron — 4 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090469
Marketing start: Jan 11, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 80425-0228_36624551-9805-e3d9-e063-6294a90aa4f6SPL ID 36624551-9805-e3d9-e063-6294a90aa4f6SPL set ID f1a0b9ee-c1d2-7818-e053-2995a90a3e96RxCUI 104894UNII 4AF302ESOS
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N480425022801 followed by a unit qualifier and the quantity

Package 80425-0228-01. 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 May 30, 2025.

Indications (excerpt from the label)

1. Indications and Usage Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 initial and repeat courses of moderately emetogenic cancer chemotherapy radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen Ondansetron orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0228

What is NDC 80425-0228?: 80425-0228 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ondansetron.
What is the active ingredient?: Ondansetron.
Who is the labeler?: Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ondansetron?: 190 other product NDCs are listed under this name. See all Ondansetron 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 Ondansetron NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	REMEDYREPACK INC.	70518-4685	70518-4685-00
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Preferred Pharmaceuticals Inc.	68788-4133	68788-4133-0168788-4133-03
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-4882	00121-4882-94
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0882	00121-0882-51
Ondansetron	Ondansetron hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous	JVET PHARMACEUTICALS LLC	86211-115	86211-0115-01
Ondansetron	Ondansetron hydrochloride 4 mg/1	TabletOral	REMEDYREPACK INC.	70518-4588	70518-4588-00
Ondansetron	Ondansetron hydrochloride 2 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-2271	00409-2271-25
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	AvKARE	42291-457	42291-0457-30
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	AvKARE	42291-458	42291-0458-30
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	St. Mary's Medical Park Pharmacy	60760-936	60760-0936-10

All 191 Ondansetron NDCs

Other NDCs under ANDA 090469

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

FDA NDC Directory listings under ANDA 090469
Product	Strength	Form · route	Labeler	Product NDC
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	Preferred Pharmaceuticals, Inc.	68788-7644
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	NuCare Pharmaceuticals,Inc.	68071-4834
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Bryant Ranch Prepack	71335-1071
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	Rising Pharma Holdings, Inc.	57237-077
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Preferred Pharmaceuticals, Inc.	68788-9559
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Rising Pharma Holdings, Inc.	57237-078
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	NuCare Pharmaceuticals,Inc.	68071-4881
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Proficient Rx LP	71205-713
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Direct Rx	61919-986
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	REMEDYREPACK INC.	70518-1551
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	St. Mary's Medical Park Pharmacy	60760-306
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	PD-Rx Pharmaceuticals, Inc.	43063-857
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	Asclemed USA, Inc.	76420-056
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	Bryant Ranch Prepack	71335-0650
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	Proficient Rx LP	63187-526
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	PD-Rx Pharmaceuticals, Inc.	43063-870
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Northwind Health Company, LLC	51655-809
Ondansetron ODTondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	Advanced Rx of Tennessee, LLC	80425-0073
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	NuCare Pharmaceuticals,Inc.	68071-2763
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	HAWAII REPACK, INC.	85534-0025

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