Prescription drug · ANDA
Gemfibrozil NDC 67046-0233
Gemfibrozil 600 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-0233-3 | 67046023303 | 30 TABLET in 1 BLISTER PACK (67046-0233-3)Marketed from Apr 29, 2026 |
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)
- Gemfibrozil
- Generic name (nonproprietary)
- gemfibrozil
- Active ingredients
- Gemfibrozil — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077836
- Marketing start
- Listing expires
- Other FDA classes
- Fibric Acids (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
- Identifiers
- Product ID 67046-0233_509e7c9a-6262-a1df-e063-6394a90aaeacSPL ID 509e7c9a-6262-a1df-e063-6394a90aaeacSPL set ID 509e6e7c-bb54-f135-e063-6294a90a5279RxCUI 310459UNII Q8X02027X3
- Pharmacologic class
- Peroxisome Proliferator Receptor alpha Agonist
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
N467046023303followed by a unit qualifier and the quantityPackage 67046-0233-03. 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 077836
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 |
|---|---|---|---|---|
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc. | 76282-225 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-107 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Cipla USA Inc. | 69097-821 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-143 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Proficient Rx LP | 63187-772 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-200 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | American Health Packaging | 60687-224 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1563 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-745 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | AvPAK | 50268-350 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1733 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-436 |