Prescription drug · ANDA

Rosuvastatin calcium NDC 50090-5970

Rosuvastatin calcium 40 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-5970Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-5970Add 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
50090-5970-05009059700030 TABLET, FILM COATED in 1 BOTTLE (50090-5970-0)Marketed from Apr 28, 2022
50090-5970-15009059700190 TABLET, FILM COATED in 1 BOTTLE (50090-5970-1)Marketed from May 4, 2022
50090-5970-250090597002100 TABLET, FILM COATED in 1 BOTTLE (50090-5970-2)Marketed from Apr 20, 2023

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 — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207752
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 50090-5970_252921c9-9d25-414b-9dc9-40585f49ba83SPL ID 252921c9-9d25-414b-9dc9-40585f49ba83SPL set ID 9b8f614f-d49c-464b-b580-5fb9f2c25681RxCUI 859419UNII 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

N450090597000 followed by a unit qualifier and the quantity

Package 50090-5970-00. 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)

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin tablets are an HMG Co‑A reductase inhibitor indicated for: adult patients with hypertriglyceridemia as an adjunct to diet (1.3) adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total‑C, and ApoB (1.5) Limitations of use (1.8) : Rosuvastatin tablets have not been studied in Fredrickso…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207752

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

FDA NDC Directory listings under ANDA 207752
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralBiocon Pharma Inc70377-008
Rosuvastatin calciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralBiocon Pharma Inc70377-006
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralBiocon Pharma Inc70377-007
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralBiocon Pharma Inc70377-009
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-793
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-801
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-052
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-133
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1890
Rosuvastatin calciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1889
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-261
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-262
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1TabletOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-263
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1TabletOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-264
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6524
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1939
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3639
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1741

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