NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1330Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1330Add 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
71335-1330-1713351330017133513300130 TABLET, FILM COATED in 1 BOTTLE (71335-1330-1)Marketed from Feb 9, 2022
71335-1330-2713351330027133513300290 TABLET, FILM COATED in 1 BOTTLE (71335-1330-2)Marketed from Feb 9, 2022
71335-1330-3713351330037133513300328 TABLET, FILM COATED in 1 BOTTLE (71335-1330-3)Marketed from Feb 9, 2022
71335-1330-4713351330047133513300460 TABLET, FILM COATED in 1 BOTTLE (71335-1330-4)Marketed from Feb 9, 2022

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 Calcium
Generic name (nonproprietary)
rosuvastatin calcium
Active ingredients
Rosuvastatin calcium — 5 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 208898
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 71335-1330_45fb199e-a292-4551-97dc-a76f8717f4deSPL ID 45fb199e-a292-4551-97dc-a76f8717f4deSPL set ID 199df185-dab0-4de1-95f7-a70e57b9c2b1RxCUI 859424UNII 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

N471335133001 followed by a unit qualifier and the quantity

Package 71335-1330-01. 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 has not been studied in Fred…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1330

What is NDC 71335-1330?
71335-1330 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 5 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Rosuvastatin Calcium.
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 Calcium?
202 other product NDCs are listed under this name. See all Rosuvastatin Calcium 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 Calcium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00569434-0005-0269434-0005-03
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00669434-0006-0269434-0006-03
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00769434-0007-0269434-0007-03
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralZhejiang Yongtai Pharmaceutical Co., Ltd.69434-00869434-0008-0169434-0008-03
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralREMEDYREPACK INC.70518-469770518-4697-00
Rosuvastatin calciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-082772303-0827-01
Rosuvastatin calciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-082872303-0828-01
Rosuvastatin calciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-082972303-0829-01
Rosuvastatin calciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralHEC Pharm USA Inc.72303-083072303-0830-01
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralShandong New Time Pharmaceutical Co., Ltd.42677-30342677-0303-0142677-0303-02

All 203 Rosuvastatin Calcium NDCs

Other NDCs under ANDA 208898

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

FDA NDC Directory listings under ANDA 208898
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-018
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-019
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-020
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1819
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralQuallent Pharmaceuticals Health LLC82009-017
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-996
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1733
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralProficient Rx LP82804-090
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-062
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5176
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6519
RosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralDIRECT RX72189-065
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-5225
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralDIRECT RX72189-106
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1017
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralProficient Rx LP82804-176
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6611
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals, Inc.68788-7612
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5110
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6612

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