What is NDC 70518-4314?

70518-4314 is the product NDC for Rosuvastatin, Rosuvastatin 40 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.

REMEDYREPACK INC., NDC labeler code 70518. 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 70518-4314 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4314Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4314Add 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
70518-4314-0	7051843140070518431400	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4314-0)Marketed from Mar 19, 2025
70518-4314-1	7051843140170518431401	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4314-1)Marketed from Apr 19, 2025
70518-4314-2	7051843140270518431402	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4314-2)Marketed from Jul 25, 2025

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 — 40 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: REMEDYREPACK INC.NDC labeler code 70518
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206381
Marketing start: Mar 19, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 70518-4314_5aa912c0-23ce-9019-e063-6294a90a0b38SPL ID 5aa912c0-23ce-9019-e063-6294a90a0b38SPL set ID a370a6c2-b5cd-4aa0-b072-a5a8017a2d5bRxCUI 859419UNII 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

N470518431400 followed by a unit qualifier and the quantity

Package 70518-4314-00. 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 Oct 26, 2026.

Indications (excerpt from the label)

Rosuvastatin tablets are indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): in adults with hypercholesterolemia. and slow the progression of atherosclerosis in adults. in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). As an adjunct to diet for the treatment of adults …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-4314

What is NDC 70518-4314?: 70518-4314 is the product NDC for Rosuvastatin, Rosuvastatin 40 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 3 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?: REMEDYREPACK INC., NDC labeler code 70518. 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 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-797
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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