Prescription drug · ANDA

Rosuvastatin Calcium NDC 0615-8533

Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8533Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8533Add 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
0615-8533-390061585333930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8533-39)Marketed from Sep 16, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079170
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 0615-8533_9feb1012-a261-4a00-a854-26cff1a6f517SPL ID 9feb1012-a261-4a00-a854-26cff1a6f517SPL set ID d84f596d-8b99-419c-9a02-4b5e26aeaea8RxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7Q
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

N400615853339 followed by a unit qualifier and the quantity

Package 00615-8533-39. 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: Reduce LDL-C in adults with primary hyperlipidemia. Reduce low-density lipoprotein cholesterol (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 hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079170

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

FDA NDC Directory listings under ANDA 079170
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8535
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8532
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8534
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-293
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-296
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-294
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7413
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-295
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7414
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralProficient Rx LP71205-078
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4710
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3722
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6522
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-235
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-245
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7486
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-234
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7487
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-256
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7489

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