Prescription drug · ANDA
Rosuvastatin Calcium NDC 68071-3623
Rosuvastatin calcium 10 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3623-9 | 68071362309 | 90 TABLET in 1 BOTTLE (68071-3623-9)Marketed from Jun 13, 2024 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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 68071-3623_1aca7a77-ea9e-3417-e063-6394a90a20bdSPL ID 1aca7a77-ea9e-3417-e063-6394a90a20bdSPL set ID 1aca7a86-940b-c6e1-e063-6294a90a5944RxCUI 859747UNII 83MVU38M7QUPC 0368071362398
- 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
N468071362309followed by a unit qualifier and the quantityPackage 68071-3623-09. 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 is 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 a…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207626
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 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8775 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4697 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7968 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7967 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3668 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7975 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7976 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3172 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-366 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-364 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-365 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-367 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4047 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4078 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-720 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-721 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-722 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-723 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-046 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-043 |
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