What is NDC 63304-458?

63304-458 is the product NDC for Ondansetron, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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 63304-458 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-458Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0458Add 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
63304-458-30	6330404583063304045830	30 TABLET, FILM COATED in 1 BOTTLE (63304-458-30)Marketed from Jun 25, 2007

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): Ondansetron
Generic name (nonproprietary): ondansetron
Active ingredients: Ondansetron hydrochloride — 4 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077851
Marketing start: Jun 25, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 63304-458_ad113c32-f57c-4548-9882-c46b9a990bd8SPL ID ad113c32-f57c-4548-9882-c46b9a990bd8SPL set ID 834bc56a-657d-4733-9a60-47040cb5c7bfRxCUI 198052, 312086UNII NMH84OZK2BUPC 0363304458305, 0363304459302
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

N463304045830 followed by a unit qualifier and the quantity

Package 63304-0458-30. 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 Sep 11, 2019.

Indications (excerpt from the label)

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/m 2 . • 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. Ondansetron tablets are a 5-HT3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-458

What is NDC 63304-458?: 63304-458 is the product NDC for Ondansetron, Ondansetron hydrochloride 4 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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 hydrochloride.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. 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 077851

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

FDA NDC Directory listings under ANDA 077851
Product	Strength	Form · route	Labeler	Product NDC
Ondansetron	Ondansetron hydrochloride 4 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-003
Ondansetron	Ondansetron hydrochloride 8 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-004
Ondansetron	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-065
Ondansetron	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-236
ondansetronondansetron hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-513
Ondansetron	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	63304-459
Ondansetronondansetron tablets	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Natco Pharma Limited	63850-0003
Ondansetronondansetron tablets	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Natco Pharma Limited	63850-0004
ondansetronondansetron hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Ascend Laboratories, LLC	67877-170
Ondansetron	Ondansetron hydrochloride 4 mg/1	TabletOral	Natco Pharma USA LLC	69339-171
Ondansetron	Ondansetron hydrochloride 8 mg/1	TabletOral	Natco Pharma USA LLC	69339-172
Ondansetron	Ondansetron hydrochloride 4 mg/1	TabletOral	REMEDYREPACK INC.	70518-4588
Ondansetron	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0132
ondansetronondansetron hydrochloride	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0815