Ondansetron NDC 43063-770

NDC codes

FDA NDC Directory

Product NDC (as listed)43063-770Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43063-0770Add 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
43063-770-06	43063077006	6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-770-06)Marketed from Mar 3, 2014

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 — 8 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: PD-Rx Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077535
Marketing start: Jun 25, 2007
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 43063-770_48d46d34-3176-1749-e063-6394a90a9a42SPL ID 48d46d34-3176-1749-e063-6394a90a9a42SPL set ID 15d0a711-ef3b-4d93-8fbc-17a45f96af8aRxCUI 312086UNII NMH84OZK2BUPC 0343063770061
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

N443063077006 followed by a unit qualifier and the quantity

Package 43063-0770-06. 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 20, 2026.

Indications (excerpt from the label)

Ondansetron is 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 is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is a 5-HT 3 receptor antagonist 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 . ( 1 ) nau…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077535

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

FDA NDC Directory listings under ANDA 077535
Product	Strength	Form · route	Labeler	Product NDC
Ondansetron	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2119
Ondansetron	Ondansetron hydrochloride 4 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-105
Ondansetron	Ondansetron hydrochloride 8 mg/1	Tablet, Film coatedOral	Glenmark Pharmaceuticals Inc., USA	68462-106