Prescription drug · ANDA

Ondansetron NDC 50090-4632

Ondansetron 8 mg/1 · Tablet, Orally disintegrating · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-4632Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-4632Add 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
50090-4632-0500904632004 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50090-4632-0)Marketed from Oct 21, 2019
50090-4632-1500904632013 BLISTER PACK in 1 CARTON (50090-4632-1) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Oct 21, 2019
50090-4632-2500904632021 BLISTER PACK in 1 CARTON (50090-4632-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Oct 21, 2019
50090-4632-3500904632032 BLISTER PACK in 1 CARTON (50090-4632-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Dec 11, 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 — 8 mg/1
Dosage form
Tablet, Orally disintegrating
Route
Oral
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 50090-4632_ef67ba26-cfad-4a52-81b2-c2ae62512b34SPL ID ef67ba26-cfad-4a52-81b2-c2ae62512b34SPL set ID 84234d20-aa73-446f-9a1b-846e0cb80cecRxCUI 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

N450090463200 followed by a unit qualifier and the quantity

Package 50090-4632-00. 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)

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 disintegratingOralHF Acquisition Co LLC, DBA HealthFirst51662-1514
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAdvanced Rx of Tennessee, LLC80425-0473
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAsclemed USA, Inc.76420-251
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-857
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-266
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-870
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-4570
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralCardinal Health 107, LLC55154-8339
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-5167
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0228
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSportpharm LLC85766-038
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-1071
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-391
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-390
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-379
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNorthStar Rx LLC16714-200
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralHF Acquisition Co LLC, DBA HealthFirst51662-1246
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNorthStar Rx LLC16714-201
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-196
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPreferred Pharmaceuticals, Inc.68788-7565

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