Prescription drug · ANDA

Rosuvastatin Calcium NDC 71335-9640

Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9640Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9640Add 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
71335-9640-17133596400130 TABLET, FILM COATED in 1 BOTTLE (71335-9640-1)Marketed from Feb 6, 2023
71335-9640-27133596400290 TABLET, FILM COATED in 1 BOTTLE (71335-9640-2)Marketed from Feb 6, 2023
71335-9640-37133596400360 TABLET, FILM COATED in 1 BOTTLE (71335-9640-3)Marketed from Feb 6, 2023
71335-9640-471335964004120 TABLET, FILM COATED in 1 BOTTLE (71335-9640-4)Marketed from Feb 6, 2023
71335-9640-571335964005180 TABLET, FILM COATED in 1 BOTTLE (71335-9640-5)Marketed from Feb 6, 2023
71335-9640-671335964006100 TABLET, FILM COATED in 1 BOTTLE (71335-9640-6)Marketed from Feb 6, 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 — 10 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 71335-9640_3531e516-f3e9-02e7-e063-6294a90a7846SPL ID 3531e516-f3e9-02e7-e063-6294a90a7846SPL set ID 4bd37cda-9928-456c-86be-aaccccf2e450RxCUI 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

N471335964001 followed by a unit qualifier and the quantity

Package 71335-9640-01. 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)

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 is 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 has not been studied in Fredrickson Typ…

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 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 coatedOralCranbury Pharmaceuticals, LLC27808-158
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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