What is NDC 71610-797?

71610-797 is the product NDC for Rosuvastatin, Rosuvastatin 10 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rosuvastatin NDC 71610-797 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-797Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0797Add 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	Copy
71610-797-15	7161007971571610079715	15 TABLET, FILM COATED in 1 BOTTLE (71610-797-15)Marketed from Mar 6, 2024
71610-797-45	7161007974571610079745	45 TABLET, FILM COATED in 1 BOTTLE (71610-797-45)Marketed from Feb 16, 2024

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 — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206381
Marketing start: Apr 24, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 71610-797_1300cf91-1b5b-05dd-e063-6294a90a4b62SPL ID 1300cf91-1b5b-05dd-e063-6294a90a4b62SPL set ID 11831846-b3ba-ba0b-e063-6394a90a4cb2RxCUI 859747UNII 413KH5ZJ73
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

N471610079715 followed by a unit qualifier and the quantity

Package 71610-0797-15. 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 Mar 6, 2024.

Indications (excerpt from the label)

Rosuvastatin tablets are indicated: To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce LDL-C in adults with primary hyperlipidemia. Reduce low-density lipoprotein cholesterol (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 hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies, or alone if such treatments …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-797

What is NDC 71610-797?: 71610-797 is the product NDC for Rosuvastatin, Rosuvastatin 10 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rosuvastatin.
What is the active ingredient?: Rosuvastatin.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rosuvastatin	Rosuvastatin 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4161	68788-4161-0368788-4161-0668788-4161-09
Rosuvastatin	Rosuvastatin calcium 5 mg/1	Tablet, CoatedOral	AiPing Pharmaceutical, Inc.	11788-130	11788-0130-0511788-0130-1011788-0130-90
Rosuvastatin	Rosuvastatin calcium 10 mg/1	Tablet, CoatedOral	AiPing Pharmaceutical, Inc.	11788-131	11788-0131-0511788-0131-1011788-0131-90
Rosuvastatin	Rosuvastatin calcium 20 mg/1	Tablet, CoatedOral	AiPing Pharmaceutical, Inc.	11788-132	11788-0132-0511788-0132-1011788-0132-90
Rosuvastatin	Rosuvastatin calcium 40 mg/1	Tablet, CoatedOral	AiPing Pharmaceutical, Inc.	11788-133	11788-0133-0511788-0133-1011788-0133-90
Rosuvastatin	Rosuvastatin 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1627	67046-1627-03
Rosuvastatin	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-189	82009-0189-05
Rosuvastatin	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-188	82009-0188-05
Rosuvastatin	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-190	82009-0190-05
Rosuvastatin	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-191	82009-0191-05

All 65 Rosuvastatin NDCs

Other NDCs under ANDA 206381

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

FDA NDC Directory listings under ANDA 206381
Product	Strength	Form · route	Labeler	Product NDC
Rosuvastatin	Rosuvastatin 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-922
Rosuvastatin	Rosuvastatin 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2539
Rosuvastatin	Rosuvastatin 20 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3847
Rosuvastatin	Rosuvastatin 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7431
Rosuvastatin	Rosuvastatin 20 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-118
Rosuvastatin	Rosuvastatin 5 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-116
Rosuvastatin	Rosuvastatin 10 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-117
Rosuvastatin	Rosuvastatin 40 mg/1	Tablet, Film coatedOral	ScieGen Pharmaceuticals, Inc.	50228-119
Rosuvastatin	Rosuvastatin 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7730
Rosuvastatin	Rosuvastatin 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7482
Rosuvastatin	Rosuvastatin 40 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7483
Rosuvastatin	Rosuvastatin 20 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4296
Rosuvastatin	Rosuvastatin 10 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4303
Rosuvastatin	Rosuvastatin 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-796
Rosuvastatin	Rosuvastatin 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7241
Rosuvastatin	Rosuvastatin 40 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4314
Rosuvastatin	Rosuvastatin 5 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7240
Rosuvastatin	Rosuvastatin 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-798
Rosuvastatin	Rosuvastatin 20 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7793
Rosuvastatin	Rosuvastatin 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4057

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