Prescription drug · ANDA
Gemfibrozil NDC 50090-6913
Gemfibrozil 600 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6913-0 | 50090691300 | 60 TABLET in 1 BOTTLE (50090-6913-0)Marketed from Dec 12, 2023 | |
| 50090-6913-2 | 50090691302 | 90 TABLET in 1 BOTTLE (50090-6913-2)Marketed from Dec 12, 2023 | |
| 50090-6913-3 | 50090691303 | 30 TABLET in 1 BOTTLE (50090-6913-3)Marketed from Dec 12, 2023 | |
| 50090-6913-4 | 50090691304 | 180 TABLET in 1 BOTTLE (50090-6913-4)Marketed from Dec 12, 2023 |
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 SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079072
- Marketing start
- Listing expires
- Other FDA classes
- PPAR alpha (Chemical structure)Peroxisome Proliferator-activated Receptor alpha Agonists (Mechanism)
- Identifiers
- Product ID 50090-6913_f0729765-9ea7-4acf-813b-f4de1fa5b717SPL ID f0729765-9ea7-4acf-813b-f4de1fa5b717SPL set ID 4907bbfa-27f4-4569-8957-9704f9c998a0RxCUI 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
N450090691300followed by a unit qualifier and the quantityPackage 50090-6913-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Gemfibrozil Tablets 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 therapy may be considered for those subjects with trig…
Excerpt only. Read the full label for complete information.
About NDC 50090-6913
- What is NDC 50090-6913?
- 50090-6913 is the product NDC for Gemfibrozil, Gemfibrozil 600 mg/1 tablet, listed with the FDA by A-S Medication Solutions. It has 4 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 | 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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-601 | 71610-0601-5371610-0601-60 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | Proficient Rx LP | 82804-221 | 82804-0221-90 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2387 | 68071-2387-0368071-2387-0668071-2387-08 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-186 | 72865-0186-0572865-0186-1872865-0186-60 |
Other NDCs under ANDA 079072
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 | Northstar RxLLC | 16714-101 |
| Gemfibrozil | Gemfibrozil 600 mg/1 | TabletOral | A-S Medication Solutions | 50090-6939 |