Prescription drug · ANDA

Rosuvastatin calcium NDC 70377-008

Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · Biocon Pharma Inc

NDC codes

FDA NDC Directory
Product NDC (as listed)70377-008Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70377-0008Add 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
70377-008-117037700081130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-008-11)Marketed from Oct 31, 2016
70377-008-127037700081290 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-008-12)Marketed from Oct 31, 2016
70377-008-1370377000813500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-008-13)Marketed from Oct 31, 2016
70377-008-15703770008151000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70377-008-15)Marketed from Sep 27, 2019

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 — 20 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 70377-008_843cb1f2-e29f-1cea-4a98-e34470827fbaSPL ID 843cb1f2-e29f-1cea-4a98-e34470827fbaSPL set ID 033d8c8f-bbe9-96b5-fd53-cb0ef929857aRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0370377008122, 0370377009112, 0370377007125, 0370377006128
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

N470377000811 followed by a unit qualifier and the quantity

Package 70377-0008-11. 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 add itional 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 hyperc…

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 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 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-052
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

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