Prescription drug · ANDA
Gemfibrozil NDC 31722-128
Gemfibrozil 600 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-128-05 | 31722012805 | 500 TABLET in 1 BOTTLE (31722-128-05)Marketed from Jan 20, 2021 | |
| 31722-128-60 | 31722012860 | 60 TABLET in 1 BOTTLE (31722-128-60)Marketed from Jan 20, 2021 |
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
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214603
- Marketing start
- Listing expires
- Other FDA classes
- PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
- Identifiers
- Product ID 31722-128_0b03cc05-5962-498a-aa5d-5f18c844cc09SPL ID 0b03cc05-5962-498a-aa5d-5f18c844cc09SPL set ID f6a2362a-21e1-442d-9f5d-9e600b5a2ea8RxCUI 310459UNII Q8X02027X3UPC 0331722128056
- 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
N431722012805followed by a unit qualifier and the quantityPackage 31722-0128-05. 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: 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 2000 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 1000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with trig…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214603
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 | Bryant Ranch Prepack | 71335-1996 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2119 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5808 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4305 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-601 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Proficient Rx LP | 82804-221 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7964 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2387 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-186 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-7809 |