Prescription drug · ANDA

Ondansetron Hydrochloride NDC 50090-3185

Ondansetron hydrochloride 8 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-3185Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-3185Add 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
50090-3185-0500903185004 TABLET, FILM COATED in 1 BOTTLE (50090-3185-0)Marketed from Jan 17, 2018
50090-3185-15009031850110 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-1)Marketed from Nov 28, 2014
50090-3185-2500903185023 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-2)Marketed from Nov 28, 2014
50090-3185-35009031850330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-3)Marketed from Nov 28, 2014
50090-3185-4500903185046 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3185-4)Marketed from Nov 28, 2014

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 Hydrochloride
Generic name (nonproprietary)
ondansetron hydrochloride
Active ingredients
Ondansetron hydrochloride — 8 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078539
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 50090-3185_f74fee7b-ae98-4fbb-84fb-23cd573e3936SPL ID f74fee7b-ae98-4fbb-84fb-23cd573e3936SPL set ID 674ea285-8f84-4603-9655-82200c523fe5RxCUI 198052, 312086UNII NMH84OZK2B

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

N450090318500 followed by a unit qualifier and the quantity

Package 50090-3185-00. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 078539

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078539
ProductStrengthForm · routeLabelerProduct NDC
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-916
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-915
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralSt. Mary's Medical Park Pharmacy60760-658
Ondansetron HydrochlorideOndansetron hydrochloride 24 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-917
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-187
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-221
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-188
Ondansetron HydrochlorideOndansetron hydrochloride 24 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-189
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralQPharma, Inc.42708-179
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-220
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-016
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2053
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralSportpharm LLC85766-006
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3178
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4245
Ondansetron HydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralProficient Rx LP63187-709
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-034
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-159
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-160
Ondansetron HydrochlorideOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1855

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