Prescription drug · ANDA
Gemfibrozil NDC 71610-107
Gemfibrozil 600 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-107-53 | 7161001075371610010753 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-107-53)Marketed from Jul 31, 2018 | |
| 71610-107-60 | 7161001076071610010760 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-107-60)Marketed from Jul 31, 2018 | |
| 71610-107-80 | 7161001078071610010780 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-107-80)Marketed from Jul 31, 2018 |
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, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077836
- Marketing start
- Listing expires
- Other FDA classes
- PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
- Identifiers
- Product ID 71610-107_54b54e0a-1488-4e0e-bffe-0980faf6f25bSPL ID 54b54e0a-1488-4e0e-bffe-0980faf6f25bSPL set ID 30a0d14a-f7a7-4ecf-99cd-6b907c8e0fe8RxCUI 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
N471610010753followed by a unit qualifier and the quantityPackage 71610-0107-53. 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.
About NDC 71610-107
- What is NDC 71610-107?
- 71610-107 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 077836
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 | PD-Rx Pharmaceuticals, Inc. | 43063-745 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | AvPAK | 50268-350 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-143 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | American Health Packaging | 60687-224 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Proficient Rx LP | 63187-772 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-436 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Coupler LLC | 67046-0233 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1733 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Cipla USA Inc. | 69097-821 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1563 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-200 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals, Inc. | 76282-225 |