Prescription drug · ANDA
ondansetron hydrochloride NDC 83270-160
Ondansetron hydrochloride 2 mg/mL · Injection · Intramuscular, Intravenous · Onesource Specialty Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83270-160-03 | 8327001600383270016003 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83270-160-03) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 30, 2023 |
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 hydrochloride
- Generic name (nonproprietary)
- ondansetron hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 2 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Onesource Specialty Pharma LimitedNDC labeler code 83270
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078244
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 83270-160_438c3d28-8bee-50f0-e063-6394a90a18e4SPL ID 438c3d28-8bee-50f0-e063-6394a90a18e4SPL set ID 438c3d28-8bed-50f0-e063-6394a90a18e4RxCUI 1740467UNII NMH84OZK2BUPC 0383270160019
- 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.
- NDC on a medical claim
N483270016003followed by a unit qualifier and the quantityPackage 83270-0160-03. 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)
Click here to enter Indications 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 O…
Excerpt only. Read the full label for complete information.
About NDC 83270-160
- What is NDC 83270-160?
- 83270-160 is the product NDC for ondansetron hydrochloride, Ondansetron hydrochloride 2 mg/mL injection, listed with the FDA by Onesource Specialty Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- ondansetron hydrochloride.
- What is the active ingredient?
- Ondansetron hydrochloride.
- Who is the labeler?
- Onesource Specialty Pharma Limited, NDC labeler code 83270. 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 hydrochloride?
- 78 other product NDCs are listed under this name. See all ondansetron hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Yes: J2405, Injection, ondansetron hydrochloride, per 1 mg. See Billing references above.
Related NDCs: other ondansetron hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Ipca Laboratories Limited | 83980-017 | 83980-0017-1083980-0017-1383980-0017-97 |
| ondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Ipca Laboratories Limited | 83980-018 | 83980-0018-1083980-0018-1383980-0018-97 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-878 | 60760-0878-10 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-088 | 87441-0088-01 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-064 | 87441-0064-01 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1242 | 67046-1242-03 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 83008-074 | 83008-0074-2083008-0074-30 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4145 | 70518-4145-0070518-4145-0170518-4145-02+3 more |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8651 | 68788-8651-0168788-8651-0268788-8651-03+2 more |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8582 | 68788-8582-0168788-8582-0268788-8582-03+2 more |