What is NDC 50228-453?

50228-453 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 40 mg/1 tablet, film coated, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Atorvastatin calcium trihydrate.

ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 50228-453 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-453Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0453Add 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	Copy
50228-453-10	50228045310	1000 TABLET, FILM COATED in 1 BOTTLE (50228-453-10)Marketed from May 19, 2016
50228-453-90	50228045390	90 TABLET, FILM COATED in 1 BOTTLE (50228-453-90)Marketed from May 19, 2016

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 — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205519
Marketing start: May 19, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 50228-453_208c33d5-23fe-47aa-b855-02586fc6dd12SPL ID 208c33d5-23fe-47aa-b855-02586fc6dd12SPL set ID f2d8b5e9-6ff2-4efa-ab01-e13df29f7371RxCUI 259255, 617310, 617311, 617312UNII 48A5M73Z4QUPC 0350228453905, 0350228454902, 0350228452052, 0350228452908, 0350228451901, 0350228451109
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

N450228045310 followed by a unit qualifier and the quantity

Package 50228-0453-10. 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 Aug 7, 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 50228-453

What is NDC 50228-453?: 50228-453 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 40 mg/1 tablet, film coated, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 2 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?: ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 205519

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

FDA NDC Directory listings under ANDA 205519
Product	Strength	Form · route	Labeler	Product NDC
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-899
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-911
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1554
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1555
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-1556
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-946
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-944
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-945
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Cipla USA Inc.,	69097-947
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-451
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-452
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-454
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-907
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1643
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-744
Atorvastatin Calcium	Atorvastatin calcium trihydrate 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-745
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-746
Atorvastatin Calcium	Atorvastatin calcium trihydrate 80 mg/1	Tablet, Film coatedOral	Radha Pharmaceuticals, Inc.	77771-454
Atorvastatin Calcium	Atorvastatin calcium trihydrate 10 mg/1	Tablet, Film coatedOral	Radha Pharmaceuticals, Inc.	77771-451
Atorvastatin Calcium	Atorvastatin calcium trihydrate 20 mg/1	Tablet, Film coatedOral	Radha Pharmaceuticals, Inc.	77771-452

Showing 20 of 31.