What is NDC 43598-745?

43598-745 is the product NDC for Ezetimibe and Simvastatin, Ezetimibe 10 mg/1; Simvastatin 80 mg/1 tablet, listed with the FDA by Dr.Reddys Laboratories Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

Dr.Reddys Laboratories Inc, NDC labeler code 43598. 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 43598-745

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-745Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0745Add 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
43598-745-05	4359807450543598074505	500 TABLET in 1 BOTTLE (43598-745-05)Marketed from Nov 20, 2018
43598-745-30	4359807453043598074530	30 TABLET in 1 BOTTLE (43598-745-30)Marketed from Nov 20, 2018
43598-745-90	4359807459043598074590	90 TABLET in 1 BOTTLE (43598-745-90)Marketed from Nov 20, 2018

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: Dr.Reddys Laboratories IncNDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200909
Marketing start: Nov 20, 2018
Marketing end: Nov 30, 2026
Other FDA classes: Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 43598-745_697ae8a7-2359-455f-9c21-e266f1c31288SPL ID 697ae8a7-2359-455f-9c21-e266f1c31288SPL set ID 023ca87a-1b04-8c17-dc4f-e2758b0771e2RxCUI 476345, 476349, 476350, 476351UNII AGG2FN16EV, EOR26LQQ24UPC 0343598745909, 0343598742908, 0343598743905, 0343598744902
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

N443598074505 followed by a unit qualifier and the quantity

Package 43598-0745-05. 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 Jul 18, 2025.

Indications (excerpt from the label)

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Ezetimibe and simvastatin tablets, which contain a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), are indicated as adjunctive therapy to diet to: • reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous famil…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-745

What is NDC 43598-745?: 43598-745 is the product NDC for Ezetimibe and Simvastatin, Ezetimibe 10 mg/1; Simvastatin 80 mg/1 tablet, listed with the FDA by Dr.Reddys Laboratories Inc. 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?: Dr.Reddys Laboratories Inc, NDC labeler code 43598. 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 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

All 24 Ezetimibe and Simvastatin NDCs

Other NDCs under ANDA 200909

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

FDA NDC Directory listings under ANDA 200909
Product	Strength	Form · route	Labeler	Product NDC
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 10 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-742
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 40 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-743
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 20 mg/1	TabletOral	Dr.Reddys Laboratories Inc	43598-744
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 10 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-190
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 20 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-191
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 40 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-192
Ezetimibe and Simvastatin	Ezetimibe 10 mg/1; Simvastatin 80 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-193