Prescription drug · ANDA

Rosuvastatin Calcium NDC 67877-441

Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · Ascend Laboratories, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)67877-441Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0441Add 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
67877-441-0567877044105500 TABLET, FILM COATED in 1 BOTTLE (67877-441-05)Marketed from Mar 21, 2017
67877-441-306787704413030 TABLET, FILM COATED in 1 BOTTLE (67877-441-30)Marketed from Mar 21, 2017
67877-441-386787704413810 TABLET, FILM COATED in 1 CARTON (67877-441-38)Marketed from Mar 21, 2017
67877-441-906787704419090 TABLET, FILM COATED in 1 BOTTLE (67877-441-90)Marketed from Mar 21, 2017

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 — 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 67877-441_e6a44b24-b851-40c2-92ef-ee7e9fe0d2dbSPL ID e6a44b24-b851-40c2-92ef-ee7e9fe0d2dbSPL set ID 4ccbaa83-d57a-421e-88a8-1cee42d4207bRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0367877441054, 0367877440903
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

N467877044105 followed by a unit qualifier and the quantity

Package 67877-0441-05. 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 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
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-190
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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