Prescription drug · ANDA
Gemfibrozil NDC 70518-4764
Gemfibrozil 600 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4764-0 | 70518476400 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4764-0)Marketed from Sep 24, 2026 |
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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202726
- Marketing start
- Listing expires
- Other FDA classes
- Fibric Acids (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
- Identifiers
- Product ID 70518-4764_5c3f719a-9596-8e70-e063-6394a90abf57SPL ID 5c3f719a-9596-8e70-e063-6394a90abf57
- 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
N470518476400followed by a unit qualifier and the quantityPackage 70518-4764-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4764
- What is NDC 70518-4764?
- 70518-4764 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 | 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 | Bryant Ranch Prepack | 71335-1996 | 71335-1996-0171335-1996-0271335-1996-03+2 more |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2119 | 72162-2119-06 |
| 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 | Camber Pharmaceuticals, Inc. | 31722-128 | 31722-0128-0531722-0128-60 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Proficient Rx LP | 82804-221 | 82804-0221-90 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-601 | 71610-0601-5371610-0601-60 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2387 | 68071-2387-0368071-2387-0668071-2387-08 |
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 | Aurobindo Pharma Limited | 65862-624 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2025 |
| 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 | Rising Pharma Holdings, Inc. | 16571-784 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8354 |