NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9726Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9726Add 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
71335-9726-0713359726007133597260090 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-0)Marketed from May 30, 2023
71335-9726-1713359726017133597260130 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-1)Marketed from May 30, 2023
71335-9726-2713359726027133597260220 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-2)Marketed from May 30, 2023
71335-9726-3713359726037133597260310 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-3)Marketed from May 30, 2023
71335-9726-471335972604713359726046 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-4)Marketed from May 30, 2023
71335-9726-5713359726057133597260560 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-5)Marketed from May 30, 2023
71335-9726-671335972606713359726069 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-6)Marketed from May 30, 2023
71335-9726-771335972607713359726075 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-7)Marketed from May 30, 2023
71335-9726-8713359726087133597260815 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-8)Marketed from May 30, 2023
71335-9726-971335972609713359726093 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-9726-9)Marketed from May 30, 2023

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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-9726_312be717-1f36-4d21-a99c-0a125764618aSPL ID 312be717-1f36-4d21-a99c-0a125764618aSPL set ID 146b21e6-f8a5-47eb-b2d9-9ed70d1501d9RxCUI 104894UNII 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

N471335972600 followed by a unit qualifier and the quantity

Package 71335-9726-00. 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 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 . (…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-9726

What is NDC 71335-9726?
71335-9726 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 4 mg/1Tablet, Orally disintegratingOralBluePoint Laboratories68001-246
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals Inc.68788-8666
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-3512
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals Inc.68788-4133
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-4115
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1658
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1659
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-2718
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAvKARE42291-457
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAvKARE42291-458
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-4685
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-273
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-2901
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-199
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-654
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralBluePoint Laboratories68001-247
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-936
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-256
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-008
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralCardinal Health 107, LLC55154-3680

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