Prescription drug · ANDA

Rosuvastatin Calcium NDC 71205-820

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

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-820Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0820Add 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
71205-820-30712050820307120508203030 TABLET, FILM COATED in 1 BOTTLE (71205-820-30)Marketed from Jul 6, 2023
71205-820-60712050820607120508206060 TABLET, FILM COATED in 1 BOTTLE (71205-820-60)Marketed from Jul 6, 2023
71205-820-90712050820907120508209090 TABLET, FILM COATED in 1 BOTTLE (71205-820-90)Marketed from Jul 6, 2023

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
Labeler
Proficient Rx LPNDC labeler code 71205
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 71205-820_76bbea68-52d8-4ba9-a772-0ba75a38f2ebSPL ID 76bbea68-52d8-4ba9-a772-0ba75a38f2ebSPL set ID 76bbea68-52d8-4ba9-a772-0ba75a38f2ebRxCUI 859747UNII 83MVU38M7QUPC 0371205820305
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

N471205082030 followed by a unit qualifier and the quantity

Package 71205-0820-30. 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 tablets 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 tablets has not been studied in …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-820

What is NDC 71205-820?
71205-820 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 10 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, 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?
Proficient Rx LP, NDC labeler code 71205. 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?
202 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 5 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00569434-0005-0269434-0005-03
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00669434-0006-0269434-0006-03
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 5 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-082772303-0827-01
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-082872303-0828-01
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 203 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 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5189
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 coatedOralBryant Ranch Prepack71335-2035

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