Prescription drug · ANDA
Rosuvastatin NDC 71335-9669
Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-9669-1 | 71335966901 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9669-1)Marketed from Apr 13, 2026 | |
| 71335-9669-2 | 71335966902 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9669-2)Marketed from Apr 4, 2023 | |
| 71335-9669-3 | 71335966903 | 28 TABLET, FILM COATED in 1 BOTTLE (71335-9669-3)Marketed from Apr 13, 2026 | |
| 71335-9669-4 | 71335966904 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9669-4)Marketed from Apr 13, 2026 | |
| 71335-9669-5 | 71335966905 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-9669-5)Marketed from Apr 13, 2026 | |
| 71335-9669-6 | 71335966906 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9669-6)Marketed from Apr 13, 2026 |
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 calcium — 20 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 207616
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-9669_5c1a3549-fe1f-4fcd-ad0b-248bf18ffd47SPL ID 5c1a3549-fe1f-4fcd-ad0b-248bf18ffd47SPL set ID e6b86b67-62c7-43cc-8174-b2b8e0a60711RxCUI 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
N471335966901followed by a unit qualifier and the quantityPackage 71335-9669-01. 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: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hyp…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207616
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 calcium 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8533 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-044 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-884 |
| Rosuvastatin | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-882 |
| Rosuvastatin | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-883 |
| Rosuvastatin | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-885 |
| Rosuvastatin | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0158 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0159 |
| Rosuvastatin | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-709 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-710 |
| Rosuvastatin | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-711 |
| Rosuvastatin | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8649 |