Prescription drug · ANDA

Rosuvastatin Calcium NDC 27808-158

Rosuvastatin calcium 40 mg/1 · Tablet, Film coated · Oral · Cranbury Pharmaceuticals, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)27808-158Labeler and product segments. Claims need a package NDC.
Product NDC at billing width27808-0158Add 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
27808-158-012780801580130 TABLET, FILM COATED in 1 BOTTLE (27808-158-01)Marketed from Jan 8, 2018
27808-158-02278080158021000 TABLET, FILM COATED in 1 BOTTLE (27808-158-02)Marketed from May 1, 2025
27808-158-0327808015803500 TABLET, FILM COATED in 1 BOTTLE (27808-158-03)Marketed from Jul 26, 2019

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 207408
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 27808-158_6c4547c4-9429-42e5-998f-e97f6a74f150SPL ID 6c4547c4-9429-42e5-998f-e97f6a74f150SPL set ID 606d16fb-82e4-420d-9456-09997562b528RxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0327808158017, 0327808156013, 0327808155023, 0327808157034, 0327808156037, 0327808156020, 0327808157010, 0327808158031, 0327808158024, 0327808155016, 0327808157027, 0327808155030
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

N427808015801 followed by a unit qualifier and the quantity

Package 27808-0158-01. 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 10 mg/1Tablet, Film coatedOralGolden State Medical Supply, Inc.51407-154
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 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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