What is NDC 68083-113?

68083-113 is the product NDC for Ondansetron, Ondansetron hydrochloride 2 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. 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.

Ondansetron NDC 68083-113 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-113Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0113Add 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 NDC	11-digit (billing)	Package	Copy
68083-113-01	6808301130168083011301	5 VIAL in 1 CARTON (68083-113-01) / 2 mL in 1 VIALMarketed from Sep 25, 2009

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 2 mg/mL
Dosage form: Injection
Route: Intramuscular, Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079224
Marketing start: Sep 25, 2009
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin 3 Receptor Antagonists (Mechanism)
Identifiers: Product ID 68083-113_89f78024-73fc-4243-a6d1-ae463b613b8cSPL ID 89f78024-73fc-4243-a6d1-ae463b613b8cSPL set ID 3efa5604-96c3-42a0-8e99-b3de4a66aa92RxCUI 1740467UNII NMH84OZK2B
Pharmacologic class: Serotonin-3 Receptor Antagonist

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 codeMed-Code curated

J2405 — Injection, ondansetron hydrochloride, per 1 mg

Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083011301 followed by a unit qualifier and the quantity

Package 68083-0113-01. 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 Jul 31, 2025.

Indications (excerpt from the label)

Ondansetron Injection is a 5-HT 3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. ( 1.1 ) • postoperative nausea and/or vomiting. ( 1.2 ) 1.1 Prevention of Nausea and Vomiting Associated With Initial and Repeat Courses of Emetogenic Cancer Chemotherapy Ondansetron Injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Ondansetron Injection is approved for patients aged 6 months and older. 1.2 Prevention of Postoperative Nausea and/or Vomiting Ondansetron Injection is indi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-113

What is NDC 68083-113?: 68083-113 is the product NDC for Ondansetron, Ondansetron hydrochloride 2 mg/mL injection, listed with the FDA by Gland Pharma Limited. 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?: Gland Pharma Limited, NDC labeler code 68083. 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?: Yes: J2405, Injection, ondansetron hydrochloride, per 1 mg. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ondansetron NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	REMEDYREPACK INC.	70518-4685	70518-4685-00
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	Preferred Pharmaceuticals Inc.	68788-4133	68788-4133-0168788-4133-03
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-4882	00121-4882-94
Ondansetron	Ondansetron hydrochloride 4 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0882	00121-0882-51
Ondansetron	Ondansetron hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous	JVET PHARMACEUTICALS LLC	86211-115	86211-0115-01
Ondansetron	Ondansetron hydrochloride 4 mg/1	TabletOral	REMEDYREPACK INC.	70518-4588	70518-4588-00
Ondansetron	Ondansetron hydrochloride 2 mg/mL	Injection, SolutionIntramuscular, Intravenous	Hospira, Inc.	0409-2271	00409-2271-25
Ondansetron	Ondansetron 4 mg/1	Tablet, Orally disintegratingOral	AvKARE	42291-457	42291-0457-30
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	AvKARE	42291-458	42291-0458-30
Ondansetron	Ondansetron 8 mg/1	Tablet, Orally disintegratingOral	St. Mary's Medical Park Pharmacy	60760-936	60760-0936-10

All 191 Ondansetron NDCs

Other NDCs under ANDA 079224

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

FDA NDC Directory listings under ANDA 079224
Product	Strength	Form · route	Labeler	Product NDC
Ondansetron	Ondansetron hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-547
Ondansetron	Ondansetron hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-548
ondansetronondansetron hydrochloride	Ondansetron hydrochloride 2 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-777
Ondansetron	Ondansetron hydrochloride 2 mg/mL	InjectionIntramuscular, Intravenous	Fosun Pharma USA Inc.	72266-123