What is NDC 16714-780?

16714-780 is the product NDC for ezetimibe and simvastatin, Ezetimibe 10 mg/1; Simvastatin 40 mg/1 tablet, listed with the FDA by NORTHSTAR RX LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

NORTHSTAR RX LLC, NDC labeler code 16714. 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 16714-780

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-780Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0780Add 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
16714-780-01	1671407800116714078001	30 TABLET in 1 BOTTLE (16714-780-01)Marketed from Aug 19, 2019
16714-780-02	1671407800216714078002	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 LLCNDC labeler code 16714
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208699
Marketing start: Aug 19, 2019
Marketing end: Oct 31, 2026
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 AGG2FN16EV, EOR26LQQ24UPC 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

N416714078001 followed by a unit qualifier and the quantity

Package 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 Sep 1, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 16714-780

What is NDC 16714-780?: 16714-780 is the product NDC for ezetimibe and simvastatin, Ezetimibe 10 mg/1; Simvastatin 40 mg/1 tablet, listed with the FDA by NORTHSTAR RX LLC. It has 2 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?: NORTHSTAR RX LLC, NDC labeler code 16714. 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 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 20 mg/1	TabletOral	Glenmark Pharmaceuticals Inc., USA	68462-322	68462-0322-1068462-0322-3068462-0322-90
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 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