Prescription drug · ANDA
Ezetimibe NDC 59651-052
Ezetimibe 10 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-052-05 | 59651005205 | 500 TABLET in 1 BOTTLE (59651-052-05)Marketed from Aug 25, 2017 | |
| 59651-052-30 | 59651005230 | 30 TABLET in 1 BOTTLE (59651-052-30)Marketed from Aug 25, 2017 | |
| 59651-052-90 | 59651005290 | 90 TABLET in 1 BOTTLE (59651-052-90)Marketed from Aug 25, 2017 |
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
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209838
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)
- Identifiers
- Product ID 59651-052_60081062-9f4b-4cf5-9c24-02b5a0b7f792SPL ID 60081062-9f4b-4cf5-9c24-02b5a0b7f792SPL set ID 726b1e63-437a-4b3b-b773-3ac47a5c0f38RxCUI 349556UNII EOR26LQQ24
- 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
N459651005205followed by a unit qualifier and the quantityPackage 59651-0052-05. 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)
Ezetimibe tablets are indicated: In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH. In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia. In combination with a statin, and other LDL-C lowering therapies, to reduce elevated LDL-C levels in adults and in pediatric patients 10…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209838
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 | Bryant Ranch Prepack | 71335-2123 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | NorthStar Rx LLC | 16714-813 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7099 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-3422 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Proficient Rx LP | 82804-064 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6631 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6630 |