What is NDC 68462-322?

68462-322 is the product NDC for ezetimibe and simvastatin, Ezetimibe 10 mg/1; Simvastatin 20 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.

Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 and simvastatin?

23 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

ezetimibe and simvastatin NDC 68462-322

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-322Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0322Add 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
68462-322-10	6846203221068462032210	1000 TABLET in 1 BOTTLE (68462-322-10)Marketed from Jun 27, 2019
68462-322-30	6846203223068462032230	30 TABLET in 1 BOTTLE (68462-322-30)Marketed from Jun 27, 2019
68462-322-90	6846203229068462032290	90 TABLET in 1 BOTTLE (68462-322-90)Marketed from Jun 27, 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 — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USANDC labeler code 68462
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208699
Marketing start: Jun 27, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 68462-322_9c80244b-f111-425c-bf4c-c8cc91300cceSPL ID 9c80244b-f111-425c-bf4c-c8cc91300cceSPL set ID 32d0e130-1211-44ca-be60-5379ffec96fdRxCUI 476345, 476349, 476350, 476351UNII AGG2FN16EV, EOR26LQQ24UPC 0368462321300, 0368462322307, 0368462323304
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

N468462032210 followed by a unit qualifier and the quantity

Package 68462-0322-10. 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 Apr 30, 2024.

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): 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 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.

Full label on DailyMed (opens in a new tab)

About NDC 68462-322

What is NDC 68462-322?: 68462-322 is the product NDC for ezetimibe and simvastatin, Ezetimibe 10 mg/1; Simvastatin 20 mg/1 tablet, listed with the FDA by Glenmark Pharmaceuticals Inc., USA. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: ezetimibe and simvastatin.
What is the active ingredient?: Ezetimibe, Simvastatin.
Who is the labeler?: Glenmark Pharmaceuticals Inc., USA, NDC labeler code 68462. 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 and simvastatin?: 23 other product NDCs are listed under this name. See all ezetimibe and simvastatin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other ezetimibe and simvastatin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 10 mg/1	TabletOral	Aurobindo Pharma Limited	59651-835	59651-0835-3059651-0835-90
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 20 mg/1	TabletOral	Aurobindo Pharma Limited	59651-836	59651-0836-3059651-0836-90
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 40 mg/1	TabletOral	Aurobindo Pharma Limited	59651-837	59651-0837-3059651-0837-90
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 80 mg/1	TabletOral	Aurobindo Pharma Limited	59651-838	59651-0838-3059651-0838-90
ezetimibe and simvastatin	Ezetimibe 10 mg/1; Simvastatin 40 mg/1	TabletOral	NORTHSTAR RX LLC	16714-780	16714-0780-0116714-0780-02
ezetimibe and simvastatin	Ezetimibe 10 mg/1; Simvastatin 80 mg/1	TabletOral	NORTHSTAR RX LLC	16714-781	16714-0781-0116714-0781-02
ezetimibe and simvastatin	Ezetimibe 10 mg/1; Simvastatin 40 mg/1	TabletOral	A-S Medication Solutions	50090-7047	50090-7047-00
ezetimibe and simvastatin	Ezetimibe 10 mg/1; Simvastatin 10 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-321	68462-0321-1068462-0321-3068462-0321-90
ezetimibe and simvastatin	Ezetimibe 10 mg/1; Simvastatin 40 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-323	68462-0323-0568462-0323-3068462-0323-90
ezetimibe and simvastatin	Ezetimibe 10 mg/1; Simvastatin 80 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-324	68462-0324-0568462-0324-3068462-0324-90

All 24 ezetimibe and simvastatin NDCs

Other NDCs under ANDA 208699

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

FDA NDC Directory listings under ANDA 208699
Product	Strength	Form · route	Labeler	Product NDC
ezetimibe and simvastatin	Ezetimibe 10 mg/1; Simvastatin 40 mg/1	TabletOral	NORTHSTAR RX LLC	16714-780
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 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