Prescription drug · ANDA

Rosuvastatin calcium NDC 71205-052

Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-052Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0052Add 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
71205-052-307120500523030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-30)Marketed from Jun 1, 2018
71205-052-607120500526060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-60)Marketed from Jun 1, 2018
71205-052-907120500529090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-052-90)Marketed from Jun 1, 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 207752
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 71205-052_5121b2d8-6afb-4875-9922-1444d6e8a465SPL ID 5121b2d8-6afb-4875-9922-1444d6e8a465SPL set ID d1bd91fd-03fa-4e6c-80c1-ce58b158d8d6RxCUI 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

N471205005230 followed by a unit qualifier and the quantity

Package 71205-0052-30. 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 calcium tablets are an HMG Co‑A reductase inhibitor indicated for: 1. adult patients with hypertriglyceridemia as an adjunct to diet (1.3) 2. adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) 3. adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total‑C, and ApoB (1.5) Limitations of use (1.8) : • Rosuvastatin calcium tablets have not…

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 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5970
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

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in