Prescription drug · ANDA

Ondansetron NDC 50090-1658

Ondansetron 4 mg/1 · Tablet, Orally disintegrating · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-1658Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-1658Add 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
50090-1658-0500901658001 BLISTER PACK in 1 PACKET (50090-1658-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 23, 2015
50090-1658-1500901658011 BLISTER PACK in 1 PACKET (50090-1658-1) / 20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 23, 2015
50090-1658-2500901658021 BLISTER PACK in 1 PACKAGE (50090-1658-2) / 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Jan 23, 2015
50090-1658-35009016580330 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (50090-1658-3)Marketed from Jan 16, 2017

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
A-S Medication SolutionsNDC labeler code 50090
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 50090-1658_7e052bf8-036e-4239-a013-f7d21537ba5cSPL ID 7e052bf8-036e-4239-a013-f7d21537ba5cSPL set ID 5a81a39b-051b-414e-a6b0-d844de4e9ab4RxCUI 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

N450090165800 followed by a unit qualifier and the quantity

Package 50090-1658-00. 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 50090-1658

What is NDC 50090-1658?
50090-1658 is the product NDC for Ondansetron, Ondansetron 4 mg/1 tablet, orally disintegrating, listed with the FDA by A-S Medication Solutions. It has 4 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?
A-S Medication Solutions, NDC labeler code 50090. 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 8 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-2635
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-199
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc.68071-2901
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralA-S Medication Solutions50090-1659
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAdvanced Rx of Tennessee, LLC80425-0469
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0222
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralProficient Rx LP63187-256
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0227
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNorthwind Health Company, LLC51655-008
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralCardinal Health 107, LLC55154-3680
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals, Inc.68071-3268
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralGlenmark Pharmaceuticals Inc., USA68462-157
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralGlenmark Pharmaceuticals Inc., USA68462-158
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralNuCare Pharmaceuticals,Inc68071-3926
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralAvKARE42291-458
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAvKARE42291-457
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-654
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralPD-Rx Pharmaceuticals, Inc.43063-273
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralBluePoint Laboratories68001-246
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralREMEDYREPACK INC.70518-3512

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