Prescription drug · ANDA
Rosuvastain Calcium NDC 62135-691
Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-691-90 | 62135069190 | 90 TABLET, FILM COATED in 1 BOTTLE (62135-691-90)Marketed from Jul 10, 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)
- Rosuvastain Calcium
- Generic name (nonproprietary)
- rosuvastain calcium
- Active ingredients
- Rosuvastatin calcium — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079168
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 62135-691_1d9afa7b-031d-18c5-e063-6294a90a6a7cSPL ID 1d9afa7b-031d-18c5-e063-6294a90a6a7cSPL set ID a12a99ef-b573-498f-be5a-deb7cd538153RxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0362135692902, 0362135690908, 0362135691905, 0362135693305
- 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
N462135069190followed by a unit qualifier and the quantityPackage 62135-0691-90. 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 079168
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 |
|---|---|---|---|---|
| Rosuvastain Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-690 |
| Rosuvastain Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-692 |
| Rosuvastain Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-693 |