Prescription drug · ANDA
Rosuvastatin Calcium NDC 63629-7157
Rosuvastatin calcium 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-7157-1 | 63629715701 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-7157-1)Marketed from Oct 16, 2017 | |
| 63629-7157-2 | 63629715702 | 90 TABLET, FILM COATED in 1 BOTTLE (63629-7157-2)Marketed from Dec 13, 2016 | |
| 63629-7157-3 | 63629715703 | 60 TABLET, FILM COATED in 1 BOTTLE (63629-7157-3)Marketed from Nov 2, 2021 | |
| 63629-7157-4 | 63629715704 | 120 TABLET, FILM COATED in 1 BOTTLE (63629-7157-4)Marketed from Jan 24, 2025 | |
| 63629-7157-5 | 63629715705 | 180 TABLET, FILM COATED in 1 BOTTLE (63629-7157-5)Marketed from Jan 24, 2025 | |
| 63629-7157-6 | 63629715706 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-7157-6)Marketed from Jan 24, 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 Calcium
- Generic name (nonproprietary)
- rosuvastatin calcium
- Active ingredients
- Rosuvastatin calcium — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079170
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-7157_29b451b9-9f2d-4f81-a3b3-ea989802a17eSPL ID 29b451b9-9f2d-4f81-a3b3-ea989802a17eSPL set ID 3dd06868-6b71-4ddd-bc9c-57e1cf6656a5RxCUI 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
N463629715701followed by a unit qualifier and the quantityPackage 63629-7157-01. 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)
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 hypercholeste…
Excerpt only. Read the full label for complete information.
About NDC 63629-7157
- What is NDC 63629-7157?
- 63629-7157 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 10 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 package NDCs, 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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?
- 199 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 079170
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 5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8532 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8533 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8534 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8535 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2449 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2451 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4710 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5676 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6522 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6637 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7413 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7414 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7486 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7487 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7489 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-235 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-168 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-169 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-170 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-171 |
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