Prescription drug · ANDA
ezetimibe and simvastatin NDC 16714-780
Ezetimibe 10 mg/1; Simvastatin 40 mg/1 · Tablet · Oral · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-780-01 | 16714078001 | 30 TABLET in 1 BOTTLE (16714-780-01)Marketed from Aug 19, 2019 | |
| 16714-780-02 | 16714078002 | 90 TABLET in 1 BOTTLE (16714-780-02)Marketed from Aug 19, 2019 |
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
- NORTHSTAR RX LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208699
- Marketing start
- Marketing end
- Other FDA classes
- Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-780_af904a13-cf99-4e52-8225-9074a05445a0SPL ID af904a13-cf99-4e52-8225-9074a05445a0SPL set ID 52a46269-2262-4052-a3ff-5455523f591fRxCUI 476345, 476349, 476350, 476351UNII EOR26LQQ24, AGG2FN16EVUPC 0316714779010
- 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
N416714078001followed by a unit qualifier and the quantityPackage 16714-0780-01. 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 and Simvastatin Tablets Ezetimibe and Simvastatin Tablets are a combination of simvastatin and ezetimibe indicated: • As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): • In adults with primary hyperlipidemia. • 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 tablets, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, no…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208699
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 | NORTHSTAR RX LLC | 16714-781 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-7047 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 10 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-321 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 20 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-322 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 40 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-323 |
| ezetimibe and simvastatin | Ezetimibe 10 mg/1; Simvastatin 80 mg/1 | TabletOral | Glenmark Pharmaceuticals Inc., USA | 68462-324 |