Prescription drug · ANDA
Ezetimibe NDC 71205-277
Ezetimibe 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-277-30 | 71205027730 | 30 TABLET in 1 BOTTLE (71205-277-30)Marketed from May 1, 2019 | |
| 71205-277-60 | 71205027760 | 60 TABLET in 1 BOTTLE (71205-277-60)Marketed from May 1, 2019 | |
| 71205-277-90 | 71205027790 | 90 TABLET in 1 BOTTLE (71205-277-90)Marketed from May 1, 2019 |
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)
- Ezetimibe
- Generic name (nonproprietary)
- ezetimibe
- Active ingredients
- Ezetimibe — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209234
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)
- Identifiers
- Product ID 71205-277_4f9db4e9-1b45-4c0e-ae3c-068627f5a953SPL ID 4f9db4e9-1b45-4c0e-ae3c-068627f5a953SPL set ID fbbe54c3-59a1-436c-aba8-188ba7ca70e0RxCUI 349556UNII EOR26LQQ24UPC 0371205277307
- Pharmacologic class
- Dietary Cholesterol Absorption Inhibitor
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
N471205027730followed by a unit qualifier and the quantityPackage 71205-0277-30. 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)
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Ezetimibe Tablet is an inhibitor of intestinal cholesterol (and related phytosterol) absorption indicated as an adjunct to diet to: • Reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary hyperlipidemia, alone or in combination with an HMG-CoA reductase inhibitor (statin) (1.1) …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209234
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 |
|---|---|---|---|---|
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-490 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7103 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1127 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-3657 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7236 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | American Health Packaging | 60687-373 |