Prescription drug · ANDA
Rosuvastatin calcium NDC 71205-008
Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-008-30 | 71205000830 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-008-30)Marketed from Apr 2, 2018 | |
| 71205-008-60 | 71205000860 | 60 TABLET, FILM COATED in 1 BOTTLE (71205-008-60)Marketed from Apr 2, 2018 | |
| 71205-008-90 | 71205000890 | 90 TABLET, FILM COATED in 1 BOTTLE (71205-008-90)Marketed from Apr 2, 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 calcium
- Generic name (nonproprietary)
- rosuvastatin calcium
- Active ingredients
- Rosuvastatin calcium — 10 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 206434
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-008_d0887230-770f-41c5-8887-83ec83afc378SPL ID d0887230-770f-41c5-8887-83ec83afc378SPL set ID 5a874865-3cbe-4589-9787-046feb9a2c46RxCUI 859747UNII 83MVU38M7QUPC 0371205008307
- 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
N471205000830followed by a unit qualifier and the quantityPackage 71205-0008-30. 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 tablets are an HMG Co‑A reductase inhibitor indicated for: • adult patients with hypertriglyceridemia as an adjunct to diet (1.3) • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet (1.4) • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL‑C, total-C, and ApoB (1.5) Limitations of use (1.8) : • Rosuvastatin calcium tablets have not be…
Excerpt only. Read the full label for complete information.