Prescription drug · ANDA
Rosuvastatin Calcium NDC 68071-3844
Rosuvastatin calcium 5 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3844-9 | 68071384409 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3844-9)Marketed from May 7, 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 Calcium
- Generic name (nonproprietary)
- rosuvastatin calcium
- Active ingredients
- Rosuvastatin calcium — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079172
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3844_4098872c-309f-465b-e063-6394a90a6da7SPL ID 4098872c-309f-465b-e063-6394a90a6da7SPL set ID 3493b809-74b0-71b0-e063-6294a90a9a99RxCUI 859424UNII 83MVU38M7QUPC 0368071384499
- 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
N468071384409followed by a unit qualifier and the quantityPackage 68071-3844-09. 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 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.
Other NDCs under ANDA 079172
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4220 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-190 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-191 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7974 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7973 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4738 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceutials Inc., USA | 68462-261 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceutials Inc., USA | 68462-262 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-989 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceutials Inc., USA | 68462-263 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceutials Inc., USA | 68462-264 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-234 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-988 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-256 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-990 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | NorthStar RxLLC | 16714-991 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-309 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2288 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2289 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc., | 68788-8368 |
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