Prescription drug · ANDA
Rosuvastatin NDC 55154-0158
Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-0158-0 | 55154015800 | 10 BLISTER PACK in 1 BAG (55154-0158-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 14, 2025 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Cardinal Health 107, LLC
- 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 55154-0158_2f27bb79-9e66-410f-8e19-139865ffd796SPL ID 2f27bb79-9e66-410f-8e19-139865ffd796SPL set ID 0f7fad2c-fc46-4ebc-b55b-6534da99e053RxCUI 859747, 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
N455154015800followed by a unit qualifier and the quantityPackage 55154-0158-00. 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 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 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 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9669 |