Prescription drug · ANDA
Ezetimibe and Simvastatin NDC 67877-509
Ezetimibe 10 mg/1; Simvastatin 40 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-509-05 | 67877050905 | 500 TABLET in 1 BOTTLE (67877-509-05)Marketed from Dec 24, 2017 | |
| 67877-509-30 | 67877050930 | 30 TABLET in 1 BOTTLE (67877-509-30)Marketed from Dec 24, 2017 | |
| 67877-509-37 | 67877050937 | 5 BLISTER PACK in 1 CARTON (67877-509-37) / 10 TABLET in 1 BLISTER PACK (67877-509-33)Marketed from Dec 24, 2017 | |
| 67877-509-90 | 67877050990 | 90 TABLET in 1 BOTTLE (67877-509-90)Marketed from Dec 24, 2017 |
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 and Simvastatin
- Generic name (nonproprietary)
- ezetimibe and simvastatin
- Active ingredients
- Ezetimibe — 10 mg/1Simvastatin — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209222
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 67877-509_ca1a42e2-f129-462a-8e87-a034da71862bSPL ID ca1a42e2-f129-462a-8e87-a034da71862bSPL set ID c90e8c96-e130-42d7-bf0d-5833652e40d5RxCUI 476345, 476349, 476350, 476351UNII EOR26LQQ24, AGG2FN16EVUPC 0367877507309, 0367877510057, 0367877508016, 0367877509907
- Pharmacologic class
- Dietary Cholesterol Absorption Inhibitor; HMG-CoA Reductase 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
N467877050905followed by a unit qualifier and the quantityPackage 67877-0509-05. 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 and Simvastatin Ezetimibe and simvastatin is a combination of simvastatin and ezetimibe indicated: • As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin Simvastatin, when used as a component of ezetimibe and simvastatin, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarc…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209222
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 and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-510 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-507 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-508 |
| Ezetimibe and Simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-4772 |