Prescription drug · ANDA

Rosuvastatin NDC 82009-190

Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · Quallent Pharmaceuticals Health LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)82009-190Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0190Add 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
82009-190-0582009019005500 TABLET, FILM COATED in 1 BOTTLE (82009-190-05)Marketed from Dec 15, 2025

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
Generic name (nonproprietary)
rosuvastatin
Active ingredients
Rosuvastatin calcium — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206465
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 82009-190_0d12ae85-71bd-4818-a82d-fd068530bd87SPL ID 0d12ae85-71bd-4818-a82d-fd068530bd87SPL set ID 0d12ae85-71bd-4818-a82d-fd068530bd87RxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0382009190051, 0382009191058
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

N482009019005 followed by a unit qualifier and the quantity

Package 82009-0190-05. 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 .

Indications (excerpt from the label)

Rosuvastatin tablets is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholester…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206465

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

FDA NDC Directory listings under ANDA 206465
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-987
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-442
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-439
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-440
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-441
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6422
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5468
RosuvastatinRosuvastatin calcium 40 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-191
RosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-188
RosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-189
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2407
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5189
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5188
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-820
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2035

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Rosuvastatin NDC 82009-190 | Med-Code