Prescription drug · ANDA
ondansetron (ondansetron hydrochloride) NDC 71335-0815
Ondansetron hydrochloride 8 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0815-0 | 71335081500 | 5 TABLET, FILM COATED in 1 BOTTLE (71335-0815-0)Marketed from Aug 24, 2012 | |
| 71335-0815-1 | 71335081501 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-0815-1)Marketed from Aug 24, 2012 | |
| 71335-0815-2 | 71335081502 | 15 TABLET, FILM COATED in 1 BOTTLE (71335-0815-2)Marketed from Aug 24, 2012 | |
| 71335-0815-3 | 71335081503 | 4 TABLET, FILM COATED in 1 BOTTLE (71335-0815-3)Marketed from Aug 24, 2012 | |
| 71335-0815-4 | 71335081504 | 3 TABLET, FILM COATED in 1 BOTTLE (71335-0815-4)Marketed from Aug 24, 2012 | |
| 71335-0815-5 | 71335081505 | 12 TABLET, FILM COATED in 1 BOTTLE (71335-0815-5)Marketed from Aug 24, 2012 | |
| 71335-0815-6 | 71335081506 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-0815-6)Marketed from Aug 24, 2012 | |
| 71335-0815-7 | 71335081507 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0815-7)Marketed from Aug 24, 2012 | |
| 71335-0815-8 | 71335081508 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0815-8)Marketed from Aug 24, 2012 | |
| 71335-0815-9 | 71335081509 | 6 TABLET, FILM COATED in 1 BOTTLE (71335-0815-9)Marketed from Aug 24, 2012 |
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 hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 8 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-0815_4633c233-c190-4611-b285-e99b5d2b7ed8SPL ID 4633c233-c190-4611-b285-e99b5d2b7ed8SPL set ID 37de0550-a6d1-46a8-a0b8-447b0dcf70adRxCUI 198052, 312086UNII 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
N471335081500followed by a unit qualifier and the quantityPackage 71335-0815-00. 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)
INDICATIONS & USAGE Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2 . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of nausea and vomiting associated with radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where …
Excerpt only. Read the full label for complete information.
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 |
|---|---|---|---|---|
| Ondansetronondansetron tablets | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Natco Pharma Limited | 63850-0004 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-236 |
| Ondansetronondansetron tablets | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Natco Pharma Limited | 63850-0003 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-459 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 63304-458 |
| 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 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-513 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0132 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-065 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-170 |
| 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 |