What is NDC 71205-355?

71205-355 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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 71205-355

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-355Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0355Add 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
71205-355-30	7120503553071205035530	30 TABLET, FILM COATED in 1 BOTTLE (71205-355-30)Marketed from Nov 1, 2019
71205-355-60	7120503556071205035560	60 TABLET, FILM COATED in 1 BOTTLE (71205-355-60)Marketed from Nov 1, 2019
71205-355-90	7120503559071205035590	90 TABLET, FILM COATED in 1 BOTTLE (71205-355-90)Marketed from Nov 1, 2019

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
Labeler: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206434
Marketing start: Oct 31, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71205-355_0ddbf155-487b-4b05-b18b-f4d8b40c746eSPL ID 0ddbf155-487b-4b05-b18b-f4d8b40c746eSPL set ID eaf91ddd-0d4f-4c77-9dba-a2a3abb86ea4RxCUI 859424UNII 83MVU38M7QUPC 0371205355302
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

N471205035530 followed by a unit qualifier and the quantity

Package 71205-0355-30. 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 Nov 1, 2022.

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 Fred…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-355

What is NDC 71205-355?: 71205-355 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 5 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?: Proficient Rx LP, NDC labeler code 71205. 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 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
Product	Strength	Form · route	Labeler	Product NDC
Rosuvastatin	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-284
Rosuvastatin	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-285
Rosuvastatin	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-286
Rosuvastatin	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-287
Rosuvastatin	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0606
Rosuvastatin	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0749
Rosuvastatin calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-008
Rosuvastatin calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-099
Rosuvastatin calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-176
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0302
Rosuvastatin calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-078
Rosuvastatin calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-187
Rosuvastatin calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-215