Prescription drug · ANDA
Ondansetron (Ondansetron tablets) NDC 63850-0004
Ondansetron hydrochloride 8 mg/1 · Tablet, Film coated · Oral · Natco Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63850-0004-1 | 6385000040163850000401 | 30 TABLET, FILM COATED in 1 BOTTLE (63850-0004-1)Marketed from Jun 25, 2007 |
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 tablets
- Active ingredients
- Ondansetron hydrochloride — 8 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Natco Pharma LimitedNDC labeler code 63850
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077851
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63850-0004_04819dac-e9c5-4d65-b8e4-15a1fd5a93c8SPL ID 04819dac-e9c5-4d65-b8e4-15a1fd5a93c8SPL set ID 59c817b7-a1c6-48a5-9bfc-2c381532bfd9RxCUI 198052, 312086UNII NMH84OZK2BUPC 0363850000317
- 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
N463850000401followed by a unit qualifier and the quantityPackage 63850-0004-01. 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 tablets are 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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are 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…
Excerpt only. Read the full label for complete information.
About NDC 63850-0004
- What is NDC 63850-0004?
- 63850-0004 is the product NDC for Ondansetron (ondansetron tablets), Ondansetron hydrochloride 8 mg/1 tablet, film coated, listed with the FDA by Natco Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ondansetron (Ondansetron Tablets).
- What is the active ingredient?
- Ondansetron hydrochloride.
- Who is the labeler?
- Natco Pharma Limited, NDC labeler code 63850. 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.
Related NDCs: other Ondansetron 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 | 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 |
Other NDCs under ANDA 077851
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 | Golden State Medical Supply, Inc. | 51407-003 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-004 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-065 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-236 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-513 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-458 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-459 |
| Ondansetronondansetron tablets | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Natco Pharma Limited | 63850-0003 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-170 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-171 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | TabletOral | Natco Pharma USA LLC | 69339-172 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4588 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0132 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0815 |