NDC codes

FDA NDC Directory
Product NDC (as listed)50268-710Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0710Add 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
50268-710-15502680710155026807101550 BLISTER PACK in 1 BOX (50268-710-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-710-11)Marketed from Dec 14, 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
Generic name (nonproprietary)
rosuvastatin
Active ingredients
Rosuvastatin calcium — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207616
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 50268-710_39ff0f38-7c7a-4ce1-e063-6394a90aa663SPL ID 39ff0f38-7c7a-4ce1-e063-6394a90aa663SPL set ID 7cd6ae8d-aa67-60db-e053-2991aa0a0edeRxCUI 859419, 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

N450268071015 followed by a unit qualifier and the quantity

Package 50268-0710-15. 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 hyp…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-710

What is NDC 50268-710?
50268-710 is the product NDC for Rosuvastatin, Rosuvastatin calcium 20 mg/1 tablet, film coated, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rosuvastatin.
What is the active ingredient?
Rosuvastatin calcium.
Who is the labeler?
AvPAK, NDC labeler code 50268. 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?
64 other product NDCs are listed under this name. See all Rosuvastatin 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
RosuvastatinRosuvastatin 5 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-416168788-4161-0368788-4161-0668788-4161-09
RosuvastatinRosuvastatin calcium 5 mg/1Tablet, CoatedOralAiPing Pharmaceutical, Inc.11788-13011788-0130-0511788-0130-1011788-0130-90
RosuvastatinRosuvastatin calcium 10 mg/1Tablet, CoatedOralAiPing Pharmaceutical, Inc.11788-13111788-0131-0511788-0131-1011788-0131-90
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, CoatedOralAiPing Pharmaceutical, Inc.11788-13211788-0132-0511788-0132-1011788-0132-90
RosuvastatinRosuvastatin calcium 40 mg/1Tablet, CoatedOralAiPing Pharmaceutical, Inc.11788-13311788-0133-0511788-0133-1011788-0133-90
RosuvastatinRosuvastatin 10 mg/1Tablet, Film coatedOralCoupler LLC67046-162767046-1627-03
RosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-18982009-0189-05
RosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-18882009-0188-05
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-19082009-0190-05
RosuvastatinRosuvastatin calcium 40 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-19182009-0191-05

All 65 Rosuvastatin NDCs

Other NDCs under ANDA 207616

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

FDA NDC Directory listings under ANDA 207616
ProductStrengthForm · routeLabelerProduct NDC
RosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-882
RosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-883
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-884
RosuvastatinRosuvastatin calcium 40 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-885
RosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAvPAK50268-709
RosuvastatinRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAvPAK50268-711
RosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0158
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-0159
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8533
RosuvastatinRosuvastatin calcium 40 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8649
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-044
RosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9669

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