NDC codes

FDA NDC Directory
Product NDC (as listed)0121-0882Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00121-0882Add 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
0121-0882-510012108825150 mL in 1 BOTTLE, PLASTIC (0121-0882-51)Marketed from Apr 20, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 hydrochloride — 4 mg/5mL
Dosage form
Solution
Route
Oral
Labeler
PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078127
Marketing start
Listing expires
Other FDA classes
Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers
Product ID 0121-0882_4e6db19b-3246-4aef-8068-74faab555710SPL ID 4e6db19b-3246-4aef-8068-74faab555710SPL set ID 68a4d845-0c1c-4867-bfca-c0fb11dc93cdRxCUI 312085UNII NMH84OZK2BUPC 0301210882517

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

N400121088251 followed by a unit qualifier and the quantity

Package 00121-0882-51. 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 oral solution 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 oral solution is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron oral solution is a 5-HT3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin great…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0882

What is NDC 0121-0882?
0121-0882 is the product NDC for Ondansetron, Ondansetron hydrochloride 4 mg/5mL solution, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ondansetron.
What is the active ingredient?
Ondansetron hydrochloride.
Who is the labeler?
PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 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 8 mg/1Tablet, Orally disintegratingOralAvKARE42291-45842291-0458-30
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralAvKARE42291-45742291-0457-30
OndansetronOndansetron 8 mg/1Tablet, Orally disintegratingOralSt. Mary's Medical Park Pharmacy60760-93660760-0936-10
OndansetronOndansetron 4 mg/1Tablet, Orally disintegratingOralIpca Laboratories Limited83980-01283980-0012-0183980-0012-1083980-0012-13+1 more

All 191 Ondansetron NDCs

Other NDCs under ANDA 078127

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

FDA NDC Directory listings under ANDA 078127
ProductStrengthForm · routeLabelerProduct NDC
OndansetronOndansetron hydrochloride 4 mg/5mLSolutionOralPAI Holdings, LLC dba PAI Pharma0121-4882

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