Prescription drug · ANDA
Rosuvastatin NDC 71335-2539
Rosuvastatin 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2539-1 | 71335253901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2539-1)Marketed from Dec 10, 2024 | |
| 71335-2539-2 | 71335253902 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2539-2)Marketed from Dec 10, 2024 | |
| 71335-2539-3 | 71335253903 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2539-3)Marketed from Dec 10, 2024 | |
| 71335-2539-4 | 71335253904 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2539-4)Marketed from Dec 10, 2024 | |
| 71335-2539-5 | 71335253905 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2539-5)Marketed from Dec 10, 2024 | |
| 71335-2539-6 | 71335253906 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2539-6)Marketed from Dec 10, 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
- Generic name (nonproprietary)
- rosuvastatin
- Active ingredients
- Rosuvastatin — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206381
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2539_c6941a72-abca-4e4c-a315-b7d054702720SPL ID c6941a72-abca-4e4c-a315-b7d054702720SPL set ID e7955483-fecd-4376-b177-c669f862a3acRxCUI 859747UNII 413KH5ZJ73
- 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
N471335253901followed by a unit qualifier and the quantityPackage 71335-2539-01. 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 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 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 hypercholeste…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206381
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 | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3847 |
| Rosuvastatin | Rosuvastatin 5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-116 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-119 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-117 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-118 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-796 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-797 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-798 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2406 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7430 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7431 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4296 |
| Rosuvastatin | Rosuvastatin 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2440 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4303 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4314 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7730 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4057 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7483 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7482 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2498 |
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