Prescription drug · ANDA

Ondansetron NDC 85534-0025

Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · HAWAII REPACK, INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)85534-0025Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85534-0025Add 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
85534-0025-08553400250010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (85534-0025-0)Marketed from Jul 17, 2026
85534-0025-18553400250120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (85534-0025-1)Marketed from Jul 17, 2026
85534-0025-28553400250230 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (85534-0025-2)Marketed from Jul 17, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 4 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
Labeler
HAWAII REPACK, INC.NDC labeler code 85534
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090469
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 85534-0025_56c8d16e-03c0-e990-e063-6294a90a0b76SPL ID 56c8d16e-03c0-e990-e063-6294a90a0b76SPL set ID b76c5cc9-f1ca-428b-8989-36a66802b650RxCUI 104894, 312087UNII 4AF302ESOS

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

N485534002500 followed by a unit qualifier and the quantity

Package 85534-0025-00. 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 orally disintegrating 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 orally disintegrating tablets also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron orally disintegrating tablets are a 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogeni…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85534-0025

What is NDC 85534-0025?
85534-0025 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by HAWAII REPACK, INC.. 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?
HAWAII REPACK, INC., NDC labeler code 85534. 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 090469

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

FDA NDC Directory listings under ANDA 090469
ProductStrengthForm · routeLabelerProduct NDC
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAdvanced Rx of Tennessee, LLC80425-0473
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAsclemed USA, Inc.76420-217
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-2763
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-5021
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-3073
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-1730
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-913
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAsclemed USA, Inc.76420-251
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralSportpharm LLC85766-213
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-266
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0228
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-4570
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-5167
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralHF Acquisition Co LLC, DBA HealthFirst51662-1514
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-857
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralCardinal Health 107, LLC55154-8339
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-870
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-4632
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-1071
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-379

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