Prescription drug · ANDA
Rosuvastatin Calcium NDC 69367-360
Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-360-01 | 69367036001 | 100 TABLET, FILM COATED in 1 BOTTLE (69367-360-01)Marketed from Dec 1, 2024 | |
| 69367-360-05 | 69367036005 | 500 TABLET, FILM COATED in 1 BOTTLE (69367-360-05)Marketed from Dec 1, 2024 | |
| 69367-360-09 | 69367036009 | 90 TABLET, FILM COATED in 1 BOTTLE (69367-360-09)Marketed from Dec 1, 2024 | |
| 69367-360-10 | 69367036010 | 1000 TABLET, FILM COATED in 1 BOTTLE (69367-360-10)Marketed from Dec 1, 2024 | |
| 69367-360-30 | 69367036030 | 30 TABLET, FILM COATED in 1 BOTTLE (69367-360-30)Marketed from Dec 1, 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 Calcium
- Generic name (nonproprietary)
- rosuvastatin calcium
- Active ingredients
- Rosuvastatin calcium — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207062
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 69367-360_447c034b-bd46-2a37-e063-6394a90a4febSPL ID 447c034b-bd46-2a37-e063-6394a90a4febSPL set ID 02797697-300a-43db-92cf-9b78f08626beRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0369367359092, 0369367359108
- 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
N469367036001followed by a unit qualifier and the quantityPackage 69367-0360-01. 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 is indicated: To reduce the risk 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: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce 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 hypercholesterole…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207062
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 5 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-359 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-362 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-361 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7492 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7490 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7491 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7493 |