Prescription drug · ANDA

Rosuvastatin Calcium NDC 68788-4078

Rosuvastatin calcium 5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-4078Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-4078Add 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
68788-4078-3687884078036878840780330 TABLET in 1 BOTTLE (68788-4078-3)Marketed from Feb 17, 2026
68788-4078-6687884078066878840780660 TABLET in 1 BOTTLE (68788-4078-6)Marketed from Feb 17, 2026
68788-4078-9687884078096878840780990 TABLET in 1 BOTTLE (68788-4078-9)Marketed from Feb 17, 2026

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
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207626
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 68788-4078_1f61e43b-0b9f-48a3-bd8e-94e66534e271SPL ID 1f61e43b-0b9f-48a3-bd8e-94e66534e271SPL set ID 1346ab60-808b-442b-8217-a59bb9986f03RxCUI 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

N468788407803 followed by a unit qualifier and the quantity

Package 68788-4078-03. 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)

Rosuvastatin tablet is 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 without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. • As an adjunct to diet to: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hyper…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-4078

What is NDC 68788-4078?
68788-4078 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 5 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?
204 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 205 Rosuvastatin Calcium NDCs

Other NDCs under ANDA 207626

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

FDA NDC Directory listings under ANDA 207626
ProductStrengthForm · routeLabelerProduct NDC
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralTORRENT PHARMACEUTICALS LIMITED13668-720
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralTORRENT PHARMACEUTICALS LIMITED13668-721
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1TabletOralTORRENT PHARMACEUTICALS LIMITED13668-722
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1TabletOralTORRENT PHARMACEUTICALS LIMITED13668-723
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralA-S Medication Solutions50090-7967
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralA-S Medication Solutions50090-7968
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralA-S Medication Solutions50090-7975
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralA-S Medication Solutions50090-7976
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralUmedica Laboratories USA Inc.60290-043
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralUmedica Laboratories USA Inc.60290-044
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1TabletOralUmedica Laboratories USA Inc.60290-045
Rosuvastatin CalciumRosuvastatin calcium 40 mg/1TabletOralUmedica Laboratories USA Inc.60290-046
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3623
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3668
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-5333
Rosuvastatin CalciumRosuvastatin calcium 20 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4047
Rosuvastatin CalciumRosuvastatin calcium 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8775
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralREMEDYREPACK INC.70518-4697
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralBryant Ranch Prepack71335-3172
Rosuvastatin CalciumRosuvastatin calcium 5 mg/1TabletOralNorthStar Rx, LLC72603-364

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