Prescription drug · ANDA
Rosuvastatin Calcium NDC 13668-181
Rosuvastatin calcium 20 mg/1 · Tablet, Coated · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-181-05 | 1366801810513668018105 | 500 TABLET, COATED in 1 BOTTLE (13668-181-05)Marketed from Oct 31, 2016 | |
| 13668-181-30 | 1366801813013668018130 | 30 TABLET, COATED in 1 BOTTLE (13668-181-30)Marketed from Oct 31, 2016 | |
| 13668-181-90 | 1366801819013668018190 | 90 TABLET, COATED in 1 BOTTLE (13668-181-90)Marketed from Oct 31, 2016 |
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, Coated
- Route
- Oral
- Labeler
- Torrent Pharmaceuticals LimitedNDC labeler code 13668
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201619
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 13668-181_a922bb47-91e3-4103-9edb-d9431a38d398SPL ID a922bb47-91e3-4103-9edb-d9431a38d398SPL set ID 8c2d481f-53f2-4cf6-bd28-7d92323785cdRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0313668180305, 0313668179309, 0313668181302, 0313668182309
- 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
N413668018105followed by a unit qualifier and the quantityPackage 13668-0181-05. 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 an HMG Co-A reductase inhibitor (statin) indicated: ( 1 ) • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for these events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): o in adults with primary hypercholesterolemia. o and slow the progression of atherosclerosis in adults. o in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). o in adults and pediatric patients aged 7 years and older with homozygous familial hyperchol…
Excerpt only. Read the full label for complete information.
About NDC 13668-181
- What is NDC 13668-181?
- 13668-181 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 20 mg/1 tablet, coated, listed with the FDA by Torrent Pharmaceuticals Limited. It has 3 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?
- Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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?
- 204 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 201619
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, CoatedOral | Torrent Pharmaceuticals Limited | 13668-179 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, CoatedOral | Torrent Pharmaceuticals Limited | 13668-180 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, CoatedOral | Torrent Pharmaceuticals Limited | 13668-182 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, CoatedOral | Northwind Health Company, LLC | 51655-756 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, CoatedOral | Bryant Ranch Prepack | 63629-7158 |