Prescription drug · ANDA

Rosuvastatin Calcium NDC 82804-176

Rosuvastatin calcium 40 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)82804-176Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0176Add 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 NDC11-digit (billing)PackageCopy
82804-176-908280401769090 TABLET, FILM COATED in 1 BOTTLE (82804-176-90)Marketed from Dec 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)
Rosuvastatin Calcium
Generic name (nonproprietary)
rosuvastatin calcium
Active ingredients
Rosuvastatin calcium — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208898
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 82804-176_dc7bfc79-9ee3-46e7-b55d-aba88648ad3bSPL ID dc7bfc79-9ee3-46e7-b55d-aba88648ad3bSPL set ID dc7bfc79-9ee3-46e7-b55d-aba88648ad3bRxCUI 859419UNII 83MVU38M7QUPC 0382804176908
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

N482804017690 followed by a unit qualifier and the quantity

Package 82804-0176-90. 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 .

Indications (excerpt from the label)

Rosuvastatin tablets are indicated: • To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: o Reduce LDL-C in adults with primary hyperlipidemia. o Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies, or alone if such…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208898

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

FDA NDC Directory listings under ANDA 208898
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-062
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-996
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralDIRECT RX72189-106
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1017
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5176
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5225
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-004
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-002
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-003
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-005
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1098
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1103
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNovadoz Pharmaceuticals LLC72205-027
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7612
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6519
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2379
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8384
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5110
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6611
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6612

Showing 20 of 32.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in