Prescription drug · ANDA

Rosuvastatin NDC 16729-287

Rosuvastatin calcium 40 mg/1 · Tablet, Film coated · Oral · Accord Healthcare Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)16729-287Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16729-0287Add 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
16729-287-101672902871030 TABLET, FILM COATED in 1 BOTTLE (16729-287-10)Marketed from Oct 31, 2016
16729-287-151672902871590 TABLET, FILM COATED in 1 BOTTLE (16729-287-15)Marketed from Oct 31, 2016
16729-287-17167290287171000 TABLET, FILM COATED in 1 BOTTLE (16729-287-17)Marketed from Oct 31, 2016

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
Generic name (nonproprietary)
rosuvastatin
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 206434
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 16729-287_4390ed19-e509-95ab-e063-6294a90a2b08SPL ID 4390ed19-e509-95ab-e063-6294a90a2b08SPL set ID 3ffe0294-3997-2755-e054-00144ff8d46cRxCUI 859419, 859424, 859747, 859751UNII 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

N416729028710 followed by a unit qualifier and the quantity

Package 16729-0287-10. 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: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholeste…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206434

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

FDA NDC Directory listings under ANDA 206434
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-355
RosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-284
RosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-285
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-286
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-008
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-078
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-099
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-187
RosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0606
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-215
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralProficient Rx LP71205-176
RosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0749
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0302

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Rosuvastatin NDC 16729-287 | Med-Code