Prescription drug · ANDA
Ezetimibe NDC 82804-211
Ezetimibe 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-211-30 | 82804021130 | 30 TABLET in 1 BOTTLE (82804-211-30)Marketed from Mar 19, 2025 |
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 078560
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)
- Identifiers
- Product ID 82804-211_55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2SPL ID 55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2SPL set ID 55b18d8f-40e0-48ba-baf1-79a0d1bb2ee2RxCUI 349556UNII EOR26LQQ24UPC 0382804211302
- 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
N482804021130followed by a unit qualifier and the quantityPackage 82804-0211-30. 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)
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 pat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078560
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 | A-S Medication Solutions | 50090-7338 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7339 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-226 |