Ezetimibe and Simvastatin NDC 59651-838

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-838Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0838Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
59651-838-30	59651083830	30 TABLET in 1 BOTTLE (59651-838-30)Marketed from Mar 1, 2024
59651-838-90	59651083890	90 TABLET in 1 BOTTLE (59651-838-90)Marketed from Mar 1, 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 and Simvastatin
Generic name (nonproprietary): ezetimibe and simvastatin
Active ingredients: Ezetimibe — 10 mg/1Simvastatin — 80 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurobindo Pharma Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200082
Marketing start: Mar 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 59651-838_0d4244dd-a226-4677-a6b2-6a1b5cd88790SPL ID 0d4244dd-a226-4677-a6b2-6a1b5cd88790SPL set ID 79dadfde-35c7-4937-9c82-1728fb6be2fbRxCUI 476345, 476349, 476350, 476351UNII EOR26LQQ24, AGG2FN16EV
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

N459651083830 followed by a unit qualifier and the quantity

Package 59651-0838-30. 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 Oct 22, 2024.

Indications (excerpt from the label)

Ezetimibe and simvastatin tablets Ezetimibe and simvastatin tablet is 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). Simv a statin 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, non-fatal …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200082

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 200082
Product	Strength	Form · route	Labeler	Product NDC
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 40 mg/1	TabletOral	Aurobindo Pharma Limited	59651-837
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 10 mg/1	TabletOral	Aurobindo Pharma Limited	59651-835
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 20 mg/1	TabletOral	Aurobindo Pharma Limited	59651-836