What is NDC 71610-633?

71610-633 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium propylene glycol solvate 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 propylene glycol solvate.

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?

383 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 71610-633 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-633Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0633Add 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
71610-633-15	71610063315	15 TABLET, FILM COATED in 1 BOTTLE (71610-633-15)Marketed from Feb 7, 2022
71610-633-30	71610063330	30 TABLET, FILM COATED in 1 BOTTLE (71610-633-30)Marketed from Feb 7, 2022
71610-633-45	71610063345	45 TABLET, FILM COATED in 1 BOTTLE (71610-633-45)Marketed from Feb 7, 2022
71610-633-60	71610063360	90 TABLET, FILM COATED in 1 BOTTLE (71610-633-60)Marketed from Feb 7, 2022

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 propylene glycol solvate — 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 090548
Marketing start: Aug 1, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71610-633_24733c5a-94ea-400b-8e16-62cf696802b1SPL ID 24733c5a-94ea-400b-8e16-62cf696802b1SPL set ID 2b7fbe2a-1f7a-4944-b589-87ca05af7481RxCUI 259255UNII YRZ789OWMI
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

N471610063315 followed by a unit qualifier and the quantity

Package 71610-0633-15. 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 Mar 2, 2022.

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 tablets are a HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-633

What is NDC 71610-633?: 71610-633 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium propylene glycol solvate 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 propylene glycol solvate.
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?: 383 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 384 Atorvastatin Calcium NDCs

Other NDCs under ANDA 090548

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

FDA NDC Directory listings under ANDA 090548
Product	Strength	Form · route	Labeler	Product NDC
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 10 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8006
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 20 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8007
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8008
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 80 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8009
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 10 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6290
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 20 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6291
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6292
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 80 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6293
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 10 mg/1	Tablet, Film coatedOral	NORTHSTAR RX LLC	16714-173
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	NORTHSTAR RX LLC	16714-175
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 80 mg/1	Tablet, Film coatedOral	NORTHSTAR RX LLC	16714-176
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 20 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-013
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 10 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-014
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	QPharma, Inc.	42708-108
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-453
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 10 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-474
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 20 mg/1	Tablet, Film coatedOral	PD-Rx Pharmaceuticals, Inc.	43063-496
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6440
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6441
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6479

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