NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0815Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0815Add 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
71335-0815-071335081500713350815005 TABLET, FILM COATED in 1 BOTTLE (71335-0815-0)Marketed from Aug 24, 2012
71335-0815-1713350815017133508150110 TABLET, FILM COATED in 1 BOTTLE (71335-0815-1)Marketed from Aug 24, 2012
71335-0815-2713350815027133508150215 TABLET, FILM COATED in 1 BOTTLE (71335-0815-2)Marketed from Aug 24, 2012
71335-0815-371335081503713350815034 TABLET, FILM COATED in 1 BOTTLE (71335-0815-3)Marketed from Aug 24, 2012
71335-0815-471335081504713350815043 TABLET, FILM COATED in 1 BOTTLE (71335-0815-4)Marketed from Aug 24, 2012
71335-0815-5713350815057133508150512 TABLET, FILM COATED in 1 BOTTLE (71335-0815-5)Marketed from Aug 24, 2012
71335-0815-6713350815067133508150620 TABLET, FILM COATED in 1 BOTTLE (71335-0815-6)Marketed from Aug 24, 2012
71335-0815-7713350815077133508150730 TABLET, FILM COATED in 1 BOTTLE (71335-0815-7)Marketed from Aug 24, 2012
71335-0815-8713350815087133508150860 TABLET, FILM COATED in 1 BOTTLE (71335-0815-8)Marketed from Aug 24, 2012
71335-0815-971335081509713350815096 TABLET, FILM COATED in 1 BOTTLE (71335-0815-9)Marketed from Aug 24, 2012

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 hydrochloride
Active ingredients
Ondansetron hydrochloride — 8 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077851
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 71335-0815_4633c233-c190-4611-b285-e99b5d2b7ed8SPL ID 4633c233-c190-4611-b285-e99b5d2b7ed8SPL set ID 37de0550-a6d1-46a8-a0b8-447b0dcf70adRxCUI 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

N471335081500 followed by a unit qualifier and the quantity

Package 71335-0815-00. 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)

INDICATIONS & USAGE Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2 . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0815

What is NDC 71335-0815?
71335-0815 is the product NDC for ondansetron (ondansetron hydrochloride), Ondansetron hydrochloride 8 mg/1 tablet, film coated, 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 (Ondansetron hydrochloride).
What is the active ingredient?
Ondansetron hydrochloride.
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?
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 077851

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

FDA NDC Directory listings under ANDA 077851
ProductStrengthForm · routeLabelerProduct NDC
OndansetronOndansetron hydrochloride 4 mg/1TabletOralGolden State Medical Supply, Inc.51407-003
OndansetronOndansetron hydrochloride 8 mg/1TabletOralGolden State Medical Supply, Inc.51407-004
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralProficient Rx LP63187-065
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralProficient Rx LP63187-236
ondansetronondansetron hydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralProficient Rx LP63187-513
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.63304-458
OndansetronOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.63304-459
Ondansetronondansetron tabletsOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralNatco Pharma Limited63850-0003
Ondansetronondansetron tabletsOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralNatco Pharma Limited63850-0004
ondansetronondansetron hydrochlorideOndansetron hydrochloride 8 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-170
OndansetronOndansetron hydrochloride 4 mg/1TabletOralNatco Pharma USA LLC69339-171
OndansetronOndansetron hydrochloride 8 mg/1TabletOralNatco Pharma USA LLC69339-172
OndansetronOndansetron hydrochloride 4 mg/1TabletOralREMEDYREPACK INC.70518-4588
OndansetronOndansetron hydrochloride 4 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0132

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