Prescription drug · ANDA

Ondansetron NDC 71205-713

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

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-713Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0713Add 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
71205-713-10712050713101 BLISTER PACK in 1 BAG (71205-713-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 17, 2022
71205-713-20712050713202 BLISTER PACK in 1 BAG (71205-713-20) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Nov 17, 2022
71205-713-307120507133030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-30)Marketed from Nov 21, 2022
71205-713-607120507136060 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-60)Marketed from Nov 21, 2022
71205-713-907120507139090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71205-713-90)Marketed from Nov 21, 2022

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 71205
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 71205-713_35203011-d93c-4169-a9cb-90b6d20b146bSPL ID 35203011-d93c-4169-a9cb-90b6d20b146bSPL set ID 47e26779-9465-410c-96b3-091119ae62f2RxCUI 312087UNII 4AF302ESOSUPC 0371205713102

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

N471205071310 followed by a unit qualifier and the quantity

Package 71205-0713-10. 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)

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 e…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-713

What is NDC 71205-713?
71205-713 is the product NDC for Ondansetron, Ondansetron 8 mg/1 tablet, orally disintegrating, listed with the FDA by Proficient Rx LP. It has 5 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 71205. 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 8 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-196
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-1071
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-379
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSportpharm LLC85766-038
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-390
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-391
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralHF Acquisition Co LLC, DBA HealthFirst51662-1246
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals, Inc.68788-7565
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNorthStar Rx LLC16714-200
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals, Inc.68788-7644
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-0650
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNorthStar Rx LLC16714-201
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-4834
Ondansetron ODTondansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAdvanced Rx of Tennessee, LLC80425-0073
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-1551
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1128
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-4881
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralRising Pharma Holdings, Inc.57237-077
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-2343
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralRising Pharma Holdings, Inc.57237-078

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