Prescription drug · ANDA

Rosuvastatin Calcium NDC 71335-2035

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

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2035Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2035Add 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
71335-2035-1713352035017133520350130 TABLET, FILM COATED in 1 BOTTLE (71335-2035-1)Marketed from Apr 3, 2024
71335-2035-2713352035027133520350290 TABLET, FILM COATED in 1 BOTTLE (71335-2035-2)Marketed from Apr 3, 2024
71335-2035-3713352035037133520350360 TABLET, FILM COATED in 1 BOTTLE (71335-2035-3)Marketed from Apr 3, 2024
71335-2035-47133520350471335203504120 TABLET, FILM COATED in 1 BOTTLE (71335-2035-4)Marketed from Jun 23, 2022
71335-2035-57133520350571335203505180 TABLET, FILM COATED in 1 BOTTLE (71335-2035-5)Marketed from Feb 2, 2022
71335-2035-67133520350671335203506100 TABLET, FILM COATED in 1 BOTTLE (71335-2035-6)Marketed from Apr 3, 2024

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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-2035_6436540d-62a8-40a5-8d94-ec34806ae8e0SPL ID 6436540d-62a8-40a5-8d94-ec34806ae8e0SPL set ID 67da041b-7ad5-4309-86b3-8c30a5f9465eRxCUI 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

N471335203501 followed by a unit qualifier and the quantity

Package 71335-2035-01. 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)

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 other LDL-C-lowering therapies, or alone if such …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2035

What is NDC 71335-2035?
71335-2035 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 coatedOralProficient Rx LP71205-820

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

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in