What is NDC 80425-0074?

80425-0074 is the product NDC for Ondansetron HCL, Ondansetron hydrochloride 8 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx 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 HCL?

2 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ondansetron HCL NDC 80425-0074 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0074Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0074Add 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
80425-0074-1	8042500740180425007401	10 TABLET, FILM COATED in 1 BOTTLE (80425-0074-1)Marketed from Sep 16, 2020
80425-0074-2	8042500740280425007402	15 TABLET, FILM COATED in 1 BOTTLE (80425-0074-2)Marketed from Sep 16, 2020
80425-0074-3	8042500740380425007403	20 TABLET, FILM COATED in 1 BOTTLE (80425-0074-3)Marketed from Sep 16, 2020
80425-0074-4	8042500740480425007404	30 TABLET, FILM COATED in 1 BOTTLE (80425-0074-4)Marketed from Sep 16, 2020
80425-0074-5	8042500740580425007405	60 TABLET, FILM COATED in 1 BOTTLE (80425-0074-5)Marketed from Sep 16, 2020
80425-0074-6	8042500740680425007406	9 TABLET, FILM COATED in 1 BOTTLE (80425-0074-6)Marketed from Sep 16, 2020

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 HCL
Generic name (nonproprietary): ondansetron hcl
Active ingredients: Ondansetron hydrochloride — 8 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078539
Marketing start: Sep 16, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 80425-0074_4ceff209-9877-7129-e063-6294a90a6fdcSPL ID 4ceff209-9877-7129-e063-6294a90a6fdcSPL set ID af735f22-6d6c-6e1f-e053-2a95a90a3532RxCUI 312086UNII NMH84OZK2B
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

N480425007401 followed by a unit qualifier and the quantity

Package 80425-0074-01. 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 Mar 13, 2026.

Indications (excerpt from the label)

1. Indications and Usage Section 1 INDICATIONS AND USAGE Ondansetron 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 tablets are 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 80425-0074

What is NDC 80425-0074?: 80425-0074 is the product NDC for Ondansetron HCL, Ondansetron hydrochloride 8 mg/1 tablet, film coated, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ondansetron HCL.
What is the active ingredient?: Ondansetron hydrochloride.
Who is the labeler?: Advanced Rx 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 HCL?: 2 other product NDCs are listed under this name. See all Ondansetron HCL 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 HCL NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ondansetron HCL	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0072	80425-0072-0180425-0072-0280425-0072-03+2 more
Ondansetron HCL	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0075	80425-0075-0180425-0075-0280425-0075-03+2 more

Other NDCs under ANDA 078539

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

FDA NDC Directory listings under ANDA 078539
Product	Strength	Form · route	Labeler	Product NDC
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8651
Ondansetron	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	PharmPak, Inc.	54348-819
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-119
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Pharmpak, Inc.	54348-821
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	St. Mary's Medical Park Pharmacy	60760-878
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-9368
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals, Inc.	68788-9402
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-076
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-075
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-792
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3511
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	72789-034
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-179
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1585
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-744
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1596
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4145
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6342
Ondansetron Hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-813
Ondansetron Hydrochloride	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-1562

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