What is NDC 59651-609?

59651-609 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 80 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Atorvastatin calcium trihydrate.

Aurobindo Pharma Limited, NDC labeler code 59651. 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 59651-609 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-609Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0609Add 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
59651-609-05	59651060905	500 TABLET, FILM COATED in 1 BOTTLE (59651-609-05)Marketed from Feb 13, 2024
59651-609-30	59651060930	30 TABLET, FILM COATED in 1 BOTTLE (59651-609-30)Marketed from Feb 13, 2024
59651-609-90	59651060990	90 TABLET, FILM COATED in 1 BOTTLE (59651-609-90)Marketed from Feb 13, 2024
59651-609-99	59651060999	1000 TABLET, FILM COATED in 1 BOTTLE (59651-609-99)Marketed from Feb 13, 2024

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: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217118
Marketing start: Feb 13, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 59651-609_b9128b7d-1e45-4f05-9f0a-26bd825e402dSPL ID b9128b7d-1e45-4f05-9f0a-26bd825e402dSPL set ID 536b5e0d-1bb9-4c9d-a588-460d7647308bRxCUI 259255, 617310, 617311, 617312UNII 48A5M73Z4QUPC 0359651607909
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

N459651060905 followed by a unit qualifier and the quantity

Package 59651-0609-05. 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 Feb 2, 2026.

Indications (excerpt from the label)

Atorvastatin calcium tablets are indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-609

What is NDC 59651-609?: 59651-609 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 80 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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 217118

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

FDA NDC Directory listings under ANDA 217118
Product	Strength	Form · route	Labeler	Product NDC
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3179
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-606
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-607
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	59651-608
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1666
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1677