Prescription drug · ANDA
rosuvstatin NDC 70756-054
Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Lifestar Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70756-054-12 | 70756005412 | 1000 TABLET, FILM COATED in 1 BOTTLE (70756-054-12)Marketed from Aug 16, 2026 | |
| 70756-054-90 | 70756005490 | 90 TABLET, FILM COATED in 1 BOTTLE (70756-054-90)Marketed from Aug 16, 2026 |
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)
- rosuvstatin
- Generic name (nonproprietary)
- rosuvstatin
- Active ingredients
- Rosuvastatin calcium — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lifestar Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206603
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 70756-054_f71a4aa4-4bf9-43c0-89bb-2d1463a34ce4SPL ID f71a4aa4-4bf9-43c0-89bb-2d1463a34ce4SPL set ID a6141eb6-0b38-44f9-9d16-ec7218a51f92RxCUI 859419, 859424, 859747, 859751UNII 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
N470756005412followed by a unit qualifier and the quantityPackage 70756-0054-12. 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 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.
Other NDCs under ANDA 206603
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 |
|---|---|---|---|---|
| rosuvstatin | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-056 |
| rosuvstatin | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-053 |
| rosuvstatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Lifestar Pharma LLC | 70756-055 |