Prescription drug · ANDA
Rosuvastatin calcium NDC 71610-187
Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-187-45 | 7161001874571610018745 | 45 TABLET, FILM COATED in 1 BOTTLE (71610-187-45)Marketed from Nov 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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-187_4abd6ed8-17d4-44d1-a30e-956ce5cc46e1SPL ID 4abd6ed8-17d4-44d1-a30e-956ce5cc46e1SPL set ID 410a0a03-6751-4c3d-82bf-c7c6a4081fddRxCUI 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
N471610018745followed by a unit qualifier and the quantityPackage 71610-0187-45. 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 been studi…
Excerpt only. Read the full label for complete information.
About NDC 71610-187
- What is NDC 71610-187?
- 71610-187 is the product NDC for Rosuvastatin calcium, Rosuvastatin calcium 20 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rosuvastatin calcium.
- What is the active ingredient?
- Rosuvastatin calcium.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rosuvastatin calcium?
- 202 other product NDCs are listed under this name. See all Rosuvastatin calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rosuvastatin calcium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-005 | 69434-0005-0269434-0005-03 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-006 | 69434-0006-0269434-0006-03 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-007 | 69434-0007-0269434-0007-03 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-008 | 69434-0008-0169434-0008-03 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4697 | 70518-4697-00 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0827 | 72303-0827-01 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0828 | 72303-0828-01 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0829 | 72303-0829-01 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0830 | 72303-0830-01 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-303 | 42677-0303-0142677-0303-02 |
Other NDCs under ANDA 206434
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 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-284 |
| Rosuvastatin | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-285 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-286 |
| Rosuvastatin | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-287 |
| Rosuvastatin | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0606 |
| Rosuvastatin | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0749 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-008 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-099 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-176 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-355 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0302 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-078 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-215 |