What is NDC 33342-318?

33342-318 is the product NDC for Atorvastatin calcium, Atorvastatin calcium trihydrate 80 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Atorvastatin calcium trihydrate.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 33342-318 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0318Add 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
33342-318-10	33342031810	90 TABLET in 1 BOTTLE (33342-318-10)Marketed from Jun 3, 2024
33342-318-11	33342031811	100 TABLET in 1 BOTTLE (33342-318-11)Marketed from May 21, 2026
33342-318-12	33342031812	10 BLISTER PACK in 1 CARTON (33342-318-12) / 10 TABLET in 1 BLISTER PACKMarketed from Jun 3, 2024
33342-318-15	33342031815	500 TABLET in 1 BOTTLE (33342-318-15)Marketed from Jun 3, 2024
33342-318-44	33342031844	1000 TABLET in 1 BOTTLE (33342-318-44)Marketed from May 27, 2026

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
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208480
Marketing start: Jun 3, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 33342-318_227d544e-2777-4da2-a626-65fa8d62209aSPL ID 227d544e-2777-4da2-a626-65fa8d62209aSPL set ID 7bd0f0ec-f7a3-4403-9a1a-11f18213631fRxCUI 259255, 617310, 617311, 617312UNII 48A5M73Z4QUPC 0333342316158, 0333342316103, 0333342315106, 0333342317155, 0333342318152, 0333342318442, 0333342315151, 0333342318107, 0333342317100
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

N433342031810 followed by a unit qualifier and the quantity

Package 33342-0318-10. 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 15, 2026.

Indications (excerpt from the label)

Atorvastatin calcium tablets is indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o 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: o Adults with primary hyperlipidemia. o Adults and pediatric patients a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-318

What is NDC 33342-318?: 33342-318 is the product NDC for Atorvastatin calcium, Atorvastatin calcium trihydrate 80 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 5 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?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 208480

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

FDA NDC Directory listings under ANDA 208480
Product	Strength	Form · route	Labeler	Product NDC
Atorvastatin calcium	Atorvastatin calcium trihydrate 10 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-315
Atorvastatin calcium	Atorvastatin calcium trihydrate 20 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-316
Atorvastatin calcium	Atorvastatin calcium trihydrate 40 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-317