Prescription drug · ANDA

Rosuvastatin calcium NDC 70518-3639

Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-3639Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-3639Add 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
70518-3639-1705183639017051836390150 POUCH in 1 BOX (70518-3639-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3639-2)Marketed from Sep 9, 2026

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
REMEDYREPACK INC.NDC labeler code 70518
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 70518-3639_5b10582e-eccc-cb01-e063-6294a90a49eeSPL ID 5b10582e-eccc-cb01-e063-6294a90a49eeSPL set ID cb942007-6ef1-4445-8dbd-6f4972148bf1RxCUI 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

N470518363901 followed by a unit qualifier and the quantity

Package 70518-3639-01. 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 are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: O Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. O Reduce 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 hyperch…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-3639

What is NDC 70518-3639?
70518-3639 is the product NDC for Rosuvastatin calcium, Rosuvastatin calcium 10 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, 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?
REMEDYREPACK INC., NDC labeler code 70518. 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?
204 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 205 Rosuvastatin calcium NDCs

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 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 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5970
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6524
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 20 mg/1Tablet, Film coatedOralBiocon Pharma Inc70377-008
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralBiocon Pharma Inc70377-009
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-052
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1741
Rosuvastatin calciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1889
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1890
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1939
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-133
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-793
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-801

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