Prescription drug · ANDA
Ezetimibe NDC 71335-0684
Ezetimibe 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0684-1 | 71335068401 | 30 TABLET in 1 BOTTLE (71335-0684-1)Marketed from Mar 2, 2018 | |
| 71335-0684-2 | 71335068402 | 90 TABLET in 1 BOTTLE (71335-0684-2)Marketed from Feb 12, 2018 | |
| 71335-0684-3 | 71335068403 | 28 TABLET in 1 BOTTLE (71335-0684-3)Marketed from Jul 9, 2024 | |
| 71335-0684-4 | 71335068404 | 18 TABLET in 1 BOTTLE (71335-0684-4)Marketed from Jul 9, 2024 | |
| 71335-0684-5 | 71335068405 | 60 TABLET in 1 BOTTLE (71335-0684-5)Marketed from Feb 17, 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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208803
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)
- Identifiers
- Product ID 71335-0684_2b1e3823-0a7c-411d-941a-2ee70251a43fSPL ID 2b1e3823-0a7c-411d-941a-2ee70251a43fSPL set ID d6b4fd12-9954-42ba-b42a-56f3747c47ffRxCUI 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
N471335068401followed by a unit qualifier and the quantityPackage 71335-0684-01. 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 208803
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.