Prescription drug · ANDA
Ondansetron NDC 17856-0691
Ondansetron hydrochloride 4 mg/5mL · Solution · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0691-1 | 17856069101 | 1.5 mL in 1 SYRINGE (17856-0691-1)Marketed from Apr 17, 2024 | |
| 17856-0691-2 | 17856069102 | 2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-2)Marketed from Apr 17, 2024 | |
| 17856-0691-4 | 17856069104 | 2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-4)Marketed from Apr 17, 2024 | |
| 17856-0691-5 | 17856069105 | 5 mL in 1 CUP (17856-0691-5)Marketed from Apr 17, 2024 | |
| 17856-0691-6 | 17856069106 | 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-6) / 1.25 mL in 1 SYRINGEMarketed from Apr 17, 2024 | |
| 17856-0691-7 | 17856069107 | 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-7) / 1.9 mL in 1 SYRINGEMarketed from Apr 17, 2024 | |
| 17856-0691-8 | 17856069108 | 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-8) / 2.5 mL in 1 SYRINGEMarketed from Apr 17, 2024 |
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
- Active ingredients
- Ondansetron hydrochloride — 4 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091483
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 17856-0691_3633ef65-d53d-4728-e063-6394a90a6205SPL ID 3633ef65-d53d-4728-e063-6394a90a6205SPL set ID e5ab38a2-5921-4320-a313-e0080c078046RxCUI 312085UNII 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 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
N417856069101followed by a unit qualifier and the quantityPackage 17856-0691-01. 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 .
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 a 5-HT 3 receptor antagonist 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 . (1) nausea and vomiting associated with initial and repeat courses …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091483
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ondansetron | Ondansetron hydrochloride 4 mg/5mL | SolutionOral | Amneal Pharmaceuticals LLC | 65162-691 |
| Ondansetron | Ondansetron hydrochloride 4 mg/5mL | SolutionOral | AvPAK | 50268-647 |
| Ondansetron | Ondansetron hydrochloride 4 mg/5mL | SolutionOral | American Health Packaging | 60687-252 |