Prescription drug · ANDA
Gemfibrozil NDC 50090-5808
Gemfibrozil 600 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5808-0 | 50090580800 | 60 TABLET in 1 BOTTLE (50090-5808-0)Marketed from Oct 15, 2021 | |
| 50090-5808-2 | 50090580802 | 90 TABLET in 1 BOTTLE (50090-5808-2)Marketed from Oct 15, 2021 | |
| 50090-5808-3 | 50090580803 | 30 TABLET in 1 BOTTLE (50090-5808-3)Marketed from Oct 15, 2021 | |
| 50090-5808-4 | 50090580804 | 180 TABLET in 1 BOTTLE (50090-5808-4)Marketed from Oct 15, 2021 |
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
- A-S Medication Solutions
- 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 50090-5808_b54f187d-2cb7-4fb7-9fae-2fc9e812667aSPL ID b54f187d-2cb7-4fb7-9fae-2fc9e812667aSPL set ID 1967afce-ce55-4b10-bd8c-e4e94130de87RxCUI 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
N450090580800followed by a unit qualifier and the quantityPackage 50090-5808-00. 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 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 | Camber Pharmaceuticals, Inc. | 31722-128 |
| 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 |