Prescription drug · ANDA
Ezetimibe NDC 82804-064
Ezetimibe 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-064-30 | 8280400643082804006430 | 30 TABLET in 1 BOTTLE (82804-064-30)Marketed from Jan 31, 2024 | |
| 82804-064-60 | 8280400646082804006460 | 60 TABLET in 1 BOTTLE (82804-064-60)Marketed from Jan 31, 2024 | |
| 82804-064-90 | 8280400649082804006490 | 90 TABLET in 1 BOTTLE (82804-064-90)Marketed from Jan 31, 2024 |
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 LPNDC labeler code 82804
- 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 82804-064_8b128e52-5d0d-4536-aa1f-be192d0989adSPL ID 8b128e52-5d0d-4536-aa1f-be192d0989adSPL set ID 8b128e52-5d0d-4536-aa1f-be192d0989adRxCUI 349556UNII EOR26LQQ24UPC 0382804064304
- 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
N482804006430followed by a unit qualifier and the quantityPackage 82804-0064-30. 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.
About NDC 82804-064
- What is NDC 82804-064?
- 82804-064 is the product NDC for Ezetimibe, Ezetimibe 10 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ezetimibe.
- What is the active ingredient?
- Ezetimibe.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ezetimibe?
- 40 other product NDCs are listed under this name. See all Ezetimibe NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ezetimibe products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Safecor Health, LLC | 48433-161 | 48433-0161-03 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Macleods Pharmaceuticals Limited | 33342-373 | 33342-0373-0733342-0373-1033342-0373-15 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-787 | 10135-0787-0510135-0787-3010135-0787-90 |
| ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-024 | 82009-0024-05 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc. | 31722-628 | 31722-0628-0131722-0628-0531722-0628-10+4 more |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7689 | 50090-7689-00 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7690 | 50090-7690-0050090-7690-01 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3092 | 71335-3092-0171335-3092-0271335-3092-03+2 more |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Orient Pharma Co., Ltd. | 76333-170 | 76333-0170-1276333-0170-1376333-0170-14+1 more |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7338 | 50090-7338-00 |
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 | NorthStar Rx LLC | 16714-813 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-3422 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6630 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6631 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7099 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-052 |
| Ezetimibe | Ezetimibe 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2123 |