Prescription drug · ANDA

Ondansetron NDC 63187-065

Ondansetron hydrochloride 8 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-065Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0065Add 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
63187-065-10631870065106318700651010 TABLET, FILM COATED in 1 BOTTLE (63187-065-10)Marketed from Apr 1, 2014
63187-065-15631870065156318700651515 TABLET, FILM COATED in 1 BOTTLE (63187-065-15)Marketed from Apr 1, 2014
63187-065-20631870065206318700652020 TABLET, FILM COATED in 1 BOTTLE (63187-065-20)Marketed from Apr 1, 2014
63187-065-30631870065306318700653030 TABLET, FILM COATED in 1 BOTTLE (63187-065-30)Marketed from Apr 1, 2014
63187-065-60631870065606318700656060 TABLET, FILM COATED in 1 BOTTLE (63187-065-60)Marketed from Apr 1, 2014
63187-065-90631870065906318700659090 TABLET, FILM COATED in 1 BOTTLE (63187-065-90)Marketed from Apr 1, 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
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077851
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63187-065_dcd5d6d3-2419-467f-91c2-50586e9ca5cbSPL ID dcd5d6d3-2419-467f-91c2-50586e9ca5cbSPL set ID 41c0dc3d-a616-425e-9073-625a0cb692c4RxCUI 198052, 312086UNII NMH84OZK2B

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

N463187006510 followed by a unit qualifier and the quantity

Package 63187-0065-10. 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)

INDICATIONS AND USAGE • Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2 . • Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. • Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. • Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patie…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-065

What is NDC 63187-065?
63187-065 is the product NDC for Ondansetron, Ondansetron hydrochloride 8 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, 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?
Proficient Rx LP, NDC labeler code 63187. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-468570518-4685-00
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals Inc.68788-413368788-4133-0168788-4133-03
OndansetronOndansetron hydrochloride 4 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-488200121-4882-94
OndansetronOndansetron hydrochloride 4 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-088200121-0882-51
OndansetronOndansetron hydrochloride 2 mg/mLInjectionIntramuscular, IntravenousJVET PHARMACEUTICALS LLC86211-11586211-0115-01
OndansetronOndansetron hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-458870518-4588-00
OndansetronOndansetron hydrochloride 2 mg/mLInjection, SolutionIntramuscular, IntravenousHospira, Inc.0409-227100409-2271-25
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAvKARE42291-45742291-0457-30
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAvKARE42291-45842291-0458-30
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-93660760-0936-10

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
ProductStrengthForm · routeLabelerProduct NDC
OndansetronOndansetron hydrochloride 4 mg/1TabletOralGolden State Medical Supply, Inc.51407-003
OndansetronOndansetron hydrochloride 8 mg/1TabletOralGolden State Medical Supply, Inc.51407-004
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralProficient Rx LP63187-236
ondansetronondansetron hydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralProficient Rx LP63187-513
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.63304-458
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.63304-459
Ondansetronondansetron tabletsOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralNatco Pharma Limited63850-0003
Ondansetronondansetron tabletsOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralNatco Pharma Limited63850-0004
ondansetronondansetron hydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-170
OndansetronOndansetron hydrochloride 4 mg/1TabletOralNatco Pharma USA LLC69339-171
OndansetronOndansetron hydrochloride 8 mg/1TabletOralNatco Pharma USA LLC69339-172
OndansetronOndansetron hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-4588
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0132
ondansetronondansetron hydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0815

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