Prescription drug · ANDA

Rosuvastatin Calcium NDC 51407-154

Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Golden State Medical Supply, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51407-154Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0154Add 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
51407-154-905140701549090 TABLET, FILM COATED in 1 BOTTLE (51407-154-90)Marketed from Nov 13, 2018

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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207408
Marketing start
Marketing end
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 51407-154_31d1bb38-738d-23fa-e063-6294a90ae0ecSPL ID 31d1bb38-738d-23fa-e063-6294a90ae0ecSPL set ID 7c3af5aa-2223-463a-e053-2a91aa0a16f9RxCUI 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

N451407015490 followed by a unit qualifier and the quantity

Package 51407-0154-90. 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 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 207408

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

FDA NDC Directory listings under ANDA 207408
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-390
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9640
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-233
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-232
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralProficient Rx LP71205-475
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-234
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralCranbury Pharmaceuticals, LLC27808-156
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralCranbury Pharmaceuticals, LLC27808-155
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralCranbury Pharmaceuticals, LLC27808-157
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralCranbury Pharmaceuticals, LLC27808-158
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3651
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0905
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2055

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