What is NDC 0615-8008?

0615-8008 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium propylene glycol solvate 40 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 6 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Atorvastatin calcium propylene glycol solvate.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 0615-8008

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8008Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8008Add 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
0615-8008-05	0061580080500615800805	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-05)Marketed from Nov 6, 2018
0615-8008-07	0061580080700615800807	7 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-07)Marketed from Nov 6, 2018
0615-8008-14	0061580081400615800814	14 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-14)Marketed from Dec 13, 2022
0615-8008-28	0061580082800615800828	28 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-28)Marketed from Apr 16, 2024
0615-8008-30	0061580083000615800830	6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8008-30) / 5 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 12, 2018
0615-8008-39	0061580083900615800839	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8008-39)Marketed from Nov 6, 2018

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090548
Marketing start: May 29, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 0615-8008_8763121c-ceae-4ce3-87fc-91909d586ac9SPL ID 8763121c-ceae-4ce3-87fc-91909d586ac9SPL set ID 40e6b63f-0a20-404a-8915-2f698877a96bRxCUI 617311UNII 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

N400615800805 followed by a unit qualifier and the quantity

Package 00615-8008-05. 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 Aug 19, 2024.

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 0615-8008

What is NDC 0615-8008?: 0615-8008 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium propylene glycol solvate 40 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 6 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?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 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 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
Atorvastatin Calcium	Atorvastatin calcium propylene glycol solvate 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-6480

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