NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0606Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0606Add 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
71335-0606-1713350606017133506060130 TABLET, FILM COATED in 1 BOTTLE (71335-0606-1)Marketed from Feb 9, 2018
71335-0606-2713350606027133506060290 TABLET, FILM COATED in 1 BOTTLE (71335-0606-2)Marketed from Jun 22, 2018
71335-0606-3713350606037133506060360 TABLET, FILM COATED in 1 BOTTLE (71335-0606-3)Marketed from Oct 30, 2024
71335-0606-47133506060471335060604120 TABLET, FILM COATED in 1 BOTTLE (71335-0606-4)Marketed from Oct 30, 2024
71335-0606-57133506060571335060605180 TABLET, FILM COATED in 1 BOTTLE (71335-0606-5)Marketed from Oct 30, 2024
71335-0606-67133506060671335060606100 TABLET, FILM COATED in 1 BOTTLE (71335-0606-6)Marketed from Oct 30, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-0606_ec7168d7-0393-4b83-96bb-f33fe04889a9SPL ID ec7168d7-0393-4b83-96bb-f33fe04889a9SPL set ID aa7443b0-9f75-47fc-a5ce-c7245444419cRxCUI 859747UNII 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

N471335060601 followed by a unit qualifier and the quantity

Package 71335-0606-01. 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)

Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin tablets are an HMG Co‑A reductase inhibitor indicated for: adult patients with hypertriglyceridemia as an adjunct to diet (1.3) adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL‑C, total-C, and ApoB (1.5) Limitations of use (1.8) : Rosuvastatin tablets have not been studied in Fredrickso…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0606

What is NDC 71335-0606?
71335-0606 is the product NDC for Rosuvastatin, Rosuvastatin calcium 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 package NDCs, 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 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
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
RosuvastatinRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAccord Healthcare Inc.16729-287
RosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0749
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralProficient Rx LP71205-008
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralProficient Rx LP71205-099
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralProficient Rx LP71205-176
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralProficient Rx LP71205-355
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0302
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-078
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-187
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-215

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