NDC codes

FDA NDC Directory
Product NDC (as listed)62756-130Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62756-0130Add 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 NDC11-digit (billing)PackageCopy
62756-130-016275601300130 TABLET, FILM COATED in 1 BOTTLE (62756-130-01)Marketed from Jun 25, 2007
62756-130-026275601300210 BLISTER PACK in 1 DOSE PACK (62756-130-02) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed 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 hydrochloride
Generic name (nonproprietary)
ondansetron hydrochloride
Active ingredients
Ondansetron hydrochloride — 4 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077050
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 62756-130_e83d90db-54a7-4c13-bd68-b1620a8aecafSPL ID e83d90db-54a7-4c13-bd68-b1620a8aecafSPL set ID 92c758a3-e749-4a15-be4b-ee30b364b2b0RxCUI 104894, 198052, 312086, 312087UNII 4AF302ESOS, NMH84OZK2BUPC 0362756131019, 0362756240834, 0362756240643, 0362756356832, 0362756130012

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

N462756013001 followed by a unit qualifier and the quantity

Package 62756-0130-01. 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 .

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. Ondansetronis 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) na…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077050

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

FDA NDC Directory listings under ANDA 077050
ProductStrengthForm · routeLabelerProduct NDC
ondansetron hydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.62756-131

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