Prescription drug · ANDA
Gemfibrozil NDC 50090-7233
Gemfibrozil 600 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7233-0 | 50090723300 | 60 TABLET, FILM COATED in 1 BOTTLE (50090-7233-0)Marketed from Aug 26, 2024 | |
| 50090-7233-2 | 50090723302 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7233-2)Marketed from Aug 26, 2024 | |
| 50090-7233-3 | 50090723303 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7233-3)Marketed from Aug 26, 2024 | |
| 50090-7233-4 | 50090723304 | 180 TABLET, FILM COATED in 1 BOTTLE (50090-7233-4)Marketed from Aug 26, 2024 |
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, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202726
- Marketing start
- Listing expires
- Other FDA classes
- PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
- Identifiers
- Product ID 50090-7233_f066ee58-5917-4c32-886d-40d1f78c6537SPL ID f066ee58-5917-4c32-886d-40d1f78c6537SPL set ID efecc680-f626-46bf-bc2b-3b5a72ba0267RxCUI 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
N450090723300followed by a unit qualifier and the quantityPackage 50090-7233-00. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Gemfibrozil tablets, USP 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 tablets, USP therapy may be considered for those …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202726
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 | NorthStar Rx LLC | 72603-206 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2025 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-624 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8354 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7234 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 16571-784 |