What is NDC 71610-036?

71610-036 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 80 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Atorvastatin calcium trihydrate.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Atorvastatin Calcium?

386 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Atorvastatin Calcium NDC 71610-036

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-036Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0036Add 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
71610-036-15	7161000361571610003615	15 TABLET, FILM COATED in 1 BOTTLE (71610-036-15)Marketed from Jan 26, 2018
71610-036-30	7161000363071610003630	30 TABLET, FILM COATED in 1 BOTTLE (71610-036-30)Marketed from Jan 26, 2018
71610-036-45	7161000364571610003645	45 TABLET, FILM COATED in 1 BOTTLE (71610-036-45)Marketed from Jan 26, 2018
71610-036-60	7161000366071610003660	90 TABLET, FILM COATED in 1 BOTTLE (71610-036-60)Marketed from Jan 31, 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): Atorvastatin Calcium
Generic name (nonproprietary): atorvastatin calcium
Active ingredients: Atorvastatin calcium trihydrate — 80 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205519
Marketing start: Nov 16, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71610-036_b294ecc8-3293-48a9-b79f-58ed5969ff43SPL ID b294ecc8-3293-48a9-b79f-58ed5969ff43SPL set ID b16b3805-7e60-447c-b3df-7a9392b63c99RxCUI 259255UNII 48A5M73Z4Q
Pharmacologic class: 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

N471610003615 followed by a unit qualifier and the quantity

Package 71610-0036-15. 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 Feb 20, 2018.

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 recommended 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. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. Atorvastatin calcium tablet is an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angin…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-036

What is NDC 71610-036?: 71610-036 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 80 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Atorvastatin Calcium.
What is the active ingredient?: Atorvastatin calcium trihydrate.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Atorvastatin Calcium?: 386 other product NDCs are listed under this name. See all Atorvastatin Calcium 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 Atorvastatin Calcium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0284	55154-0284-06
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-681	72189-0681-30
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3585	00480-3585-1000480-3585-98
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	Unit Dose Solutions, Inc.	87441-013	87441-0013-01
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3586	00480-3586-1000480-3586-98
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3587	00480-3587-1000480-3587-98
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1677	67046-1677-03
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-3588	00480-3588-1000480-3588-98
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1666	67046-1666-03
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	TabletOral	REMEDYREPACK INC.	70518-4592	70518-4592-00

All 387 Atorvastatin Calcium NDCs

Other NDCs under ANDA 205519

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

FDA NDC Directory listings under ANDA 205519
Product	Strength	Form · route	Labeler	Product NDC
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-451
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-452
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-453
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-454
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-907
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-8469
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-8470
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-8471
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-8472
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1643
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3267
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-897
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-898
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-899
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-911
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-944
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-945
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-946
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-947
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-163

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