Prescription drug · ANDA
Gemfibrozil NDC 0615-8354
Gemfibrozil 600 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8354-39 | 0061583543900615835439 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8354-39)Marketed from Nov 10, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- 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 0615-8354_41a6e05c-7bec-43e1-803c-e600dce780fcSPL ID 41a6e05c-7bec-43e1-803c-e600dce780fcSPL set ID 394dfb45-cd3c-4e1e-8dd6-7e4867e90a03RxCUI 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
N400615835439followed by a unit qualifier and the quantityPackage 00615-8354-39. 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.
About NDC 0615-8354
- What is NDC 0615-8354?
- 0615-8354 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Gemfibrozil.
- What is the active ingredient?
- Gemfibrozil.
- Who is the labeler?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Gemfibrozil?
- 42 other product NDCs are listed under this name. See all Gemfibrozil NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gemfibrozil products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4764 | 70518-4764-00 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Coupler LLC | 67046-0233 | 67046-0233-03 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4305 | 70518-4305-00 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7964 | 68788-7964-0368788-7964-0668788-7964-09 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-128 | 31722-0128-0531722-0128-60 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-5808 | 50090-5808-0050090-5808-0250090-5808-03+1 more |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-7809 | 50090-7809-00 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2387 | 68071-2387-0368071-2387-0668071-2387-08 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1996 | 71335-1996-0171335-1996-0271335-1996-03+2 more |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-601 | 71610-0601-5371610-0601-60 |
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 | Rising Pharma Holdings, Inc. | 16571-784 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7233 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7234 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-624 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4764 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2025 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 72603-206 |