Prescription drug · ANDA
Ondansetron Hydrochloride NDC 43063-792
Ondansetron hydrochloride 8 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-792-06 | 43063079206 | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-792-06)Marketed from Oct 6, 2017 |
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 Hydrochloride
- Generic name (nonproprietary)
- ondansetron hydrochloride
- Active ingredients
- Ondansetron hydrochloride — 8 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078539
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin 3 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43063-792_3ed9a18c-3975-d837-e063-6394a90a8f1eSPL ID 3ed9a18c-3975-d837-e063-6394a90a8f1eSPL set ID 0b675b09-fe40-435c-b91a-c61cdf767fbfRxCUI 312086UNII NMH84OZK2BUPC 0343063792063
- 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
N443063079206followed by a unit qualifier and the quantityPackage 43063-0792-06. 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 equ…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078539
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 Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-916 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-915 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-658 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 24 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-917 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-187 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-221 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-188 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 24 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-189 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-179 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-220 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-016 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2053 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-006 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3178 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4245 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-3185 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-709 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-034 |
| Ondansetron | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-159 |
| Ondansetron | Ondansetron hydrochloride 8 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 16714-160 |
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