Prescription drug · ANDA
Ondansetron NDC 62135-351
Ondansetron hydrochloride 8 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-351-05 | 62135035105 | 500 TABLET in 1 BOTTLE (62135-351-05)Marketed from Apr 20, 2022 | |
| 62135-351-30 | 62135035130 | 30 TABLET in 1 BOTTLE (62135-351-30)Marketed from Apr 20, 2022 |
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 — 8 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077303
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62135-351_06fce9d8-ee18-4486-e063-6394a90aeeb4SPL ID 06fce9d8-ee18-4486-e063-6394a90aeeb4SPL set ID 88b7432b-f5a7-40f3-9b0c-e7b125f5103cRxCUI 198052, 312086UNII NMH84OZK2BUPC 0362135351052, 0362135350055, 0362135351304, 0362135350307
- 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
N462135035105followed by a unit qualifier and the quantityPackage 62135-0351-05. 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 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 is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron 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 ) naus…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077303
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/1 | TabletOral | Chartwell RX, LLC | 62135-350 |