Prescription drug · ANDA
Rosuvastatin calcium NDC 71335-1890
Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1890-1 | 71335189001 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-1)Marketed from Feb 18, 2022 | |
| 71335-1890-2 | 71335189002 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-2)Marketed from Jul 14, 2021 | |
| 71335-1890-3 | 71335189003 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-3)Marketed from Mar 10, 2022 | |
| 71335-1890-4 | 71335189004 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-4)Marketed from Mar 10, 2022 | |
| 71335-1890-5 | 71335189005 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-5)Marketed from Mar 10, 2022 | |
| 71335-1890-6 | 71335189006 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1890-6)Marketed from Mar 10, 2022 |
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 calcium
- Generic name (nonproprietary)
- rosuvastatin calcium
- Active ingredients
- Rosuvastatin calcium — 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 207752
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1890_d662b4b1-af33-4c0a-9499-d9865ae049eeSPL ID d662b4b1-af33-4c0a-9499-d9865ae049eeSPL set ID 51d0ef20-c80d-44de-ac85-9b73608dba0bRxCUI 859747UNII 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
N471335189001followed by a unit qualifier and the quantityPackage 71335-1890-01. 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)
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 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 tablets have not been studied in Fredrickso…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207752
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 calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc | 70377-008 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc | 70377-006 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc | 70377-007 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Biocon Pharma Inc | 70377-009 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-793 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-801 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5970 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-052 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-133 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1889 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-261 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-262 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-263 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-264 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6524 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1939 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3639 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1741 |