Prescription drug · ANDA

Ondansetron NDC 71335-1314

Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1314Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1314Add 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
71335-1314-0713351314007133513140090 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-0)Marketed from Sep 9, 2019
71335-1314-1713351314017133513140130 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-1)Marketed from Sep 20, 2019
71335-1314-2713351314027133513140220 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-2)Marketed from May 14, 2020
71335-1314-3713351314037133513140310 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-3)Marketed from Sep 11, 2019
71335-1314-471335131404713351314046 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-4)Marketed from Sep 16, 2019
71335-1314-5713351314057133513140560 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-5)Marketed from Nov 26, 2019
71335-1314-671335131406713351314069 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-6)Marketed from Apr 3, 2024
71335-1314-771335131407713351314075 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-7)Marketed from Oct 18, 2019
71335-1314-8713351314087133513140815 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-8)Marketed from Oct 14, 2019
71335-1314-971335131409713351314093 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-9)Marketed from Nov 5, 2020

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 090469
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 71335-1314_b16468ac-e482-41d2-ac22-966ad7807bcfSPL ID b16468ac-e482-41d2-ac22-966ad7807bcfSPL set ID ee668456-a214-4452-ab9d-ec00eaa41d79RxCUI 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

N471335131400 followed by a unit qualifier and the quantity

Package 71335-1314-00. 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 71335-1314

What is NDC 71335-1314?
71335-1314 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?
189 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 hydrochloride 2 mg/mLInjectionIntramuscular, IntravenousApotex Corp.60505-493960505-4939-02
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-468570518-4685-0070518-4685-01
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

All 190 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 disintegratingOralNorthStar Rx LLC16714-200
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNorthStar Rx LLC16714-201
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-857
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-870
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1128
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1200
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1201
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-2343
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-4632
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-196
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-809
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-913
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralHF Acquisition Co LLC, DBA HealthFirst51662-1246
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralHF Acquisition Co LLC, DBA HealthFirst51662-1514
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralCardinal Health 107, LLC55154-8339
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralRising Pharma Holdings, Inc.57237-077
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralRising Pharma Holdings, Inc.57237-078
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-306
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralDirect Rx61919-986
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-266

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