What is NDC 71335-2055?

71335-2055 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 40 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rosuvastatin Calcium NDC 71335-2055

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2055Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2055Add 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 NDC	11-digit (billing)	Package
71335-2055-1	7133520550171335205501	30 TABLET, FILM COATED in 1 BOTTLE (71335-2055-1)Marketed from Mar 14, 2022
71335-2055-2	7133520550271335205502	90 TABLET, FILM COATED in 1 BOTTLE (71335-2055-2)Marketed from Mar 14, 2022
71335-2055-3	7133520550371335205503	28 TABLET, FILM COATED in 1 BOTTLE (71335-2055-3)Marketed from Mar 14, 2022
71335-2055-4	7133520550471335205504	10 TABLET, FILM COATED in 1 BOTTLE (71335-2055-4)Marketed from Mar 14, 2022
71335-2055-5	7133520550571335205505	60 TABLET, FILM COATED in 1 BOTTLE (71335-2055-5)Marketed from Jul 10, 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 Calcium
Generic name (nonproprietary): rosuvastatin calcium
Active ingredients: Rosuvastatin calcium — 40 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 207408
Marketing start: Jan 8, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71335-2055_5acc5f32-0f8d-441b-b591-4559f612cbb8SPL ID 5acc5f32-0f8d-441b-b591-4559f612cbb8SPL set ID c277c6fd-f8dd-41d8-8686-38c25d05d192RxCUI 859419UNII 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

N471335205501 followed by a unit qualifier and the quantity

Package 71335-2055-01. 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 Aug 29, 2024.

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 is 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 has not been studied in Fredrickson Typ…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2055

What is NDC 71335-2055?: 71335-2055 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 40 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rosuvastatin Calcium	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Zhejiang Yongtai Pharmaceutical Co., Ltd.	69434-005	69434-0005-0269434-0005-03
Rosuvastatin Calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Zhejiang Yongtai Pharmaceutical Co., Ltd.	69434-006	69434-0006-0269434-0006-03
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Zhejiang Yongtai Pharmaceutical Co., Ltd.	69434-007	69434-0007-0269434-0007-03
Rosuvastatin Calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Zhejiang Yongtai Pharmaceutical Co., Ltd.	69434-008	69434-0008-0169434-0008-03
Rosuvastatin Calcium	Rosuvastatin calcium 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4697	70518-4697-00
Rosuvastatin calcium	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	HEC Pharm USA Inc.	72303-0827	72303-0827-01
Rosuvastatin calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	HEC Pharm USA Inc.	72303-0828	72303-0828-01
Rosuvastatin calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	HEC Pharm USA Inc.	72303-0829	72303-0829-01
Rosuvastatin calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	HEC Pharm USA Inc.	72303-0830	72303-0830-01
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Shandong New Time Pharmaceutical Co., Ltd.	42677-303	42677-0303-0142677-0303-02

All 203 Rosuvastatin Calcium NDCs

Other NDCs under ANDA 207408

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

FDA NDC Directory listings under ANDA 207408
Product	Strength	Form · route	Labeler	Product NDC
Rosuvastatin Calcium	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Cranbury Pharmaceuticals, LLC	27808-155
Rosuvastatin Calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Cranbury Pharmaceuticals, LLC	27808-156
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Cranbury Pharmaceuticals, LLC	27808-157
Rosuvastatin Calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Cranbury Pharmaceuticals, LLC	27808-158
Rosuvastatin Calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3651
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-390
Rosuvastatin Calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-475
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0905
Rosuvastatin Calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-9640
Rosuvastatin Calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-232
Rosuvastatin Calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-233
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-234