Atorvastatin Calcium NDC 42385-940

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-940Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0940Add 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
42385-940-01	42385094001	100 TABLET, FILM COATED in 1 BOTTLE (42385-940-01)Marketed from Jan 23, 2024
42385-940-05	42385094005	500 TABLET, FILM COATED in 1 BOTTLE (42385-940-05)Marketed from Jan 23, 2024
42385-940-11	42385094011	1000 TABLET, FILM COATED in 1 BOTTLE (42385-940-11)Marketed from Jan 23, 2024
42385-940-30	42385094030	30 TABLET, FILM COATED in 1 BOTTLE (42385-940-30)Marketed from Jan 23, 2024
42385-940-68	42385094068	10 BLISTER PACK in 1 CARTON (42385-940-68) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42385-940-10)Marketed from Jan 23, 2024
42385-940-90	42385094090	90 TABLET, FILM COATED in 1 BOTTLE (42385-940-90)Marketed from Jan 23, 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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Laurus Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214513
Marketing start: Jan 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 42385-940_ba8208d7-c3b8-4ddc-8826-9f5265513bfaSPL ID ba8208d7-c3b8-4ddc-8826-9f5265513bfaSPL set ID 9f8ca507-b784-4d18-8d3e-d7d68072c416RxCUI 259255, 617310, 617311, 617312UNII 48A5M73Z4QUPC 0342385943306, 0342385940305, 0342385942309, 0342385941302, 0342385943085
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

N442385094001 followed by a unit qualifier and the quantity

Package 42385-0940-01. 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 Apr 22, 2024.

Indications (excerpt from the label)

Atorvastatin calcium tablets are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214513

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

FDA NDC Directory listings under ANDA 214513
Product	Strength	Form · route	Labeler	Product NDC
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3144
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-941
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-942
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Laurus Labs Limited	42385-943