Prescription drug · ANDA
Ezetimibe NDC 31722-628
Ezetimibe 10 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-628-01 | 31722062801 | 100 TABLET in 1 BOTTLE (31722-628-01)Marketed from Jul 26, 2022 | |
| 31722-628-05 | 31722062805 | 500 TABLET in 1 BOTTLE (31722-628-05)Marketed from Sep 25, 2023 | |
| 31722-628-10 | 31722062810 | 1000 TABLET in 1 BOTTLE (31722-628-10)Marketed from Sep 25, 2023 | |
| 31722-628-30 | 31722062830 | 30 TABLET in 1 BOTTLE (31722-628-30)Marketed from Jul 26, 2022 | |
| 31722-628-31 | 31722062831 | 100 BLISTER PACK in 1 CARTON (31722-628-31) / 10 TABLET in 1 BLISTER PACKMarketed from Jul 26, 2022 | |
| 31722-628-34 | 31722062834 | 100 BLISTER PACK in 1 CARTON (31722-628-34) / 10 TABLET in 1 BLISTER PACKMarketed from Jul 26, 2022 | |
| 31722-628-90 | 31722062890 | 90 TABLET in 1 BOTTLE (31722-628-90)Marketed from Jul 26, 2022 |
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
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210859
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)
- Identifiers
- Product ID 31722-628_1d93c66e-c5ea-de6f-e063-6294a90acfb8SPL ID 1d93c66e-c5ea-de6f-e063-6294a90acfb8SPL set ID c07fe2e0-dad4-48b5-8a07-7d57a4035ccdRxCUI 349556UNII EOR26LQQ24UPC 0331722628051, 0331722628303, 0331722628907
- 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
N431722062801followed by a unit qualifier and the quantityPackage 31722-0628-01. 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 pat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210859
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.