Prescription drug · ANDA
Gemfibrozil NDC 71610-200
Gemfibrozil 600 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-200-60 | 71610020060 | 90 TABLET in 1 BOTTLE (71610-200-60)Marketed from Nov 28, 2018 |
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)
- Gemfibrozil
- Generic name (nonproprietary)
- gemfibrozil
- Active ingredients
- Gemfibrozil — 600 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077836
- Marketing start
- Listing expires
- Other FDA classes
- PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
- Identifiers
- Product ID 71610-200_540018a9-7f17-4295-9d61-7ce5adce89f7SPL ID 540018a9-7f17-4295-9d61-7ce5adce89f7SPL set ID eb1a2edf-587e-42c5-a98b-58646bc3f948RxCUI 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
N471610020060followed by a unit qualifier and the quantityPackage 71610-0200-60. 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 | TabletOral | Coupler LLC | 67046-0233 |
| 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 | 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 |