Prescription drug · ANDA
Ondansetron Hydrochloride NDC 68084-220
Ondansetron hydrochloride 4 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68084-220-01 | 68084022001 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-220-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-220-11)Marketed from Sep 21, 2023 |
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 — 4 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- American Health Packaging
- 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 68084-220_55186a1c-6346-db4e-e063-6394a90ad0afSPL ID 55186a1c-6346-db4e-e063-6394a90ad0afSPL set ID 9f015e60-1aec-4ae7-b28f-42f6c8f50455RxCUI 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
N468084022001followed by a unit qualifier and the quantityPackage 68084-0220-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 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 |
| Ondansetron Hydrochloride | Ondansetron hydrochloride 4 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1855 |
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