Prescription drug · ANDA
Rosuvastatin NDC 71205-044
Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-044-30 | 71205004430 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-044-30)Marketed from Jan 29, 2025 | |
| 71205-044-90 | 71205004490 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-044-90)Marketed from Jun 1, 2018 |
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)
- Rosuvastatin
- Generic name (nonproprietary)
- rosuvastatin
- Active ingredients
- Rosuvastatin calcium — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 71205-044_99925b18-b0ac-49c2-8cd0-47ec54265506SPL ID 99925b18-b0ac-49c2-8cd0-47ec54265506SPL set ID f42139aa-bb38-4791-b41e-cd8f2c922529RxCUI 859751UNII 83MVU38M7QUPC 0371205044909
- 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
N471205004430followed by a unit qualifier and the quantityPackage 71205-0044-30. 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)
Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Rosuvastatin calcium tablet is an HMG Co-A reductase inhibitor indicated for: • adult patients with hypertriglyceridemia as an adjunct to diet ( Error! Hyperlink reference not valid. ) • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet ( Error! Hyperlink reference not valid. ) • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB ( Err…
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 | 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 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9669 |