Prescription drug · ANDA
ondansetron (ondansetron hydrochloride) NDC 0904-6551
Ondansetron hydrochloride 4 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6551-61 | 00904655161 | 100 BLISTER PACK in 1 CARTON (0904-6551-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Dec 26, 2006 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076183
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0904-6551_c966171f-89bb-402a-b56a-fcc3f43df9f9SPL ID c966171f-89bb-402a-b56a-fcc3f43df9f9SPL set ID a29b5c18-9884-4c88-8827-65d9ad5f69f6RxCUI 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
N400904655161followed by a unit qualifier and the quantityPackage 00904-6551-61. 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 5-HT 3 receptor antagonist indicated for the prevention of: nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin greater than or eq…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076183
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 hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3551 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-153 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-154 |
| ondansetron hydrochloride | Ondansetron hydrochloride 16 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-155 |
| Ondansetronondansetron hydrochloride | Ondansetron hydrochloride 24 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Limited | 55111-156 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1539 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | HF Acquisition Co LLC, DBA HealthFirst | 51662-1678 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6552 |
| ondansetron hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8185 |
| ondansetronondansetron hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-7879 |