Prescription drug · ANDA

Rosuvastatin Calcium NDC 16714-991

Rosuvastatin calcium 40 mg/1 · Tablet, Film coated · Oral · NorthStar RxLLC

NDC codes

FDA NDC Directory
Product NDC (as listed)16714-991Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0991Add 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
16714-991-011671409910130 TABLET, FILM COATED in 1 BOTTLE (16714-991-01)Marketed from Jun 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 — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 079172
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 16714-991_af3a6349-8b25-462d-9fbf-3e95c32734dfSPL ID af3a6349-8b25-462d-9fbf-3e95c32734dfSPL set ID 17d71c80-fade-4735-acec-60738d26dd01RxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0316714990019, 0316714988016, 0316714989013, 0316714991016
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

N416714099101 followed by a unit qualifier and the quantity

Package 16714-0991-01. 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 hy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 079172

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 079172
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3844
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4220
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralQPharma, Inc.42708-190
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralQPharma, Inc.42708-191
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7974
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7973
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4738
Rosuvastatin calciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralGlenmark Pharmaceutials Inc., USA68462-261
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralGlenmark Pharmaceutials Inc., USA68462-262
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-989
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralGlenmark Pharmaceutials Inc., USA68462-263
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralGlenmark Pharmaceutials Inc., USA68462-264
Rosuvastatin calciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralProficient Rx LP82804-234
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-988
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-256
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralNorthStar RxLLC16714-990
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-309
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralRedpharm Drug67296-2288
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralRedpharm Drug67296-2289
Rosuvastatin calciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.,68788-8368

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Rosuvastatin Calcium NDC 16714-991 | Med-Code