Prescription drug · ANDA

Rosuvastatin Calcium NDC 50090-5189

Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-5189Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5189Add 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
50090-5189-0500905189005009051890090 TABLET, FILM COATED in 1 BOTTLE (50090-5189-0)Marketed from Sep 29, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Labeler
A-S Medication SolutionsNDC labeler code 50090
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 50090-5189_68b52be2-fca7-4329-89f2-bac216c405a1SPL ID 68b52be2-fca7-4329-89f2-bac216c405a1SPL set ID 7b2fc012-bf45-4a27-9e48-67926972918dRxCUI 859747UNII 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

N450090518900 followed by a unit qualifier and the quantity

Package 50090-5189-00. 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 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: o Reduce LDL-C in adults with primary hyperlipidemia. o Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to diet for the treatment of adults with: o Primary …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50090-5189

What is NDC 50090-5189?
50090-5189 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 10 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rosuvastatin Calcium.
What is the active ingredient?
Rosuvastatin calcium.
Who is the labeler?
A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rosuvastatin Calcium?
203 other product NDCs are listed under this name. See all Rosuvastatin Calcium NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Rosuvastatin Calcium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00669434-0006-0269434-0006-03
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00569434-0005-0269434-0005-03
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00769434-0007-0269434-0007-03
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00869434-0008-0169434-0008-03
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralREMEDYREPACK INC.70518-469770518-4697-00
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-082872303-0828-01
Rosuvastatin calciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-082772303-0827-01
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-082972303-0829-01
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-083072303-0830-01
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralShandong New Time Pharmaceutical Co., Ltd.42677-30342677-0303-0142677-0303-02

All 204 Rosuvastatin Calcium NDCs

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
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
RosuvastatinRosuvastatin calcium 40 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-191
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5188
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5468
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6422
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-987
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 40 mg/1Tablet, Film coatedOralAscend Laboratories, LLC67877-442
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2407
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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