NDC codes

FDA NDC Directory
Product NDC (as listed)71209-043Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71209-0043Add 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
71209-043-047120900430490 TABLET, FILM COATED in 1 BOTTLE (71209-043-04)Marketed from Nov 21, 2018

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 — 5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207453
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 71209-043_1fa3517d-f34d-430d-89e0-8b4c9d923f77SPL ID 1fa3517d-f34d-430d-89e0-8b4c9d923f77SPL set ID 6802a946-a29c-4d41-997b-3c078ed8e74dRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0371209045049, 0371209044042, 0371209043045
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

N471209004304 followed by a unit qualifier and the quantity

Package 71209-0043-04. 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 at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207453

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

FDA NDC Directory listings under ANDA 207453
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-045
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-044
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-046

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Rosuvastatin Calcium NDC 71209-043 | Med-Code