Prescription drug · ANDA
Ezetimibe NDC 50090-6631
Ezetimibe 10 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6631-0 | 50090663100 | 90 TABLET in 1 BOTTLE (50090-6631-0)Marketed from Aug 25, 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)
- Ezetimibe
- Generic name (nonproprietary)
- ezetimibe
- Active ingredients
- Ezetimibe — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-6631_d3bd72a5-a1e9-41e0-98bd-9b2529f10da4SPL ID d3bd72a5-a1e9-41e0-98bd-9b2529f10da4SPL set ID a1cc2018-72a3-48bc-90de-c460f224cf5aRxCUI 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
N450090663100followed by a unit qualifier and the quantityPackage 50090-6631-00. 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 .
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 | Aurobindo Pharma Limited | 59651-052 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Proficient Rx LP | 82804-064 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6630 |