Prescription drug · ANDA

Ondansetron NDC 63187-199

Ondansetron 8 mg/1 · Tablet, Orally disintegrating · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-199Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0199Add 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
63187-199-106318701991010 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-10)Marketed from Oct 1, 2014
63187-199-206318701992020 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-20)Marketed from Nov 11, 2025
63187-199-306318701993030 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-199-30)Marketed from Sep 25, 2025

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 — 8 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078152
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 63187-199_3ccb1196-6b72-478b-ba07-b05849ae83e6SPL ID 3ccb1196-6b72-478b-ba07-b05849ae83e6SPL set ID 81366c85-c6c9-4a9a-9fe5-cdd8c2d19f74RxCUI 104894, 312087UNII 4AF302ESOSUPC 0363187256050

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

N463187019910 followed by a unit qualifier and the quantity

Package 63187-0199-10. 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 patien…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-199

What is NDC 63187-199?
63187-199 is the product NDC for Ondansetron, Ondansetron 8 mg/1 tablet, orally disintegrating, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ondansetron.
What is the active ingredient?
Ondansetron.
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 078152

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

FDA NDC Directory listings under ANDA 078152
ProductStrengthForm · routeLabelerProduct NDC
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc68071-3926
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-273
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAvKARE42291-457
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAvKARE42291-458
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralBluePoint Laboratories68001-246
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralBluePoint Laboratories68001-247
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals Inc.68788-8666
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-3512
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-936
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-4115
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals Inc.68788-4133
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAdvanced Rx of Tennessee, LLC80425-0469
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-9726
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-2718
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0222
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0227
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1659
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1658
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-4685
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-2901

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