Prescription drug · ANDA
Gemfibrozil NDC 76282-225
Gemfibrozil 600 mg/1 · Tablet, Film coated · Oral · Exelan Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76282-225-05 | 76282022505 | 500 TABLET, FILM COATED in 1 BOTTLE (76282-225-05)Marketed from Oct 20, 2006 | |
| 76282-225-18 | 76282022518 | 180 TABLET, FILM COATED in 1 BOTTLE (76282-225-18)Marketed from Oct 20, 2006 | |
| 76282-225-60 | 76282022560 | 60 TABLET, FILM COATED in 1 BOTTLE (76282-225-60)Marketed from Oct 20, 2006 |
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, Film coated
- Route
- Oral
- Labeler
- Exelan Pharmaceuticals, Inc.
- 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 76282-225_9d0b053e-d825-4af2-b923-35d7709da23eSPL ID 9d0b053e-d825-4af2-b923-35d7709da23eSPL set ID 5c09fe54-697e-4cd5-9a26-7c9c7fa9a864RxCUI 310459UNII Q8X02027X3UPC 0376282225609
- 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
N476282022505followed by a unit qualifier and the quantityPackage 76282-0225-05. 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)
INDICATIONS AND USAGE Gemfibrozil Tablets are indicated as adjunctive therapy to diet for: 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with…
Excerpt only. Read the full label for complete information.
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 | 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 | 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 |