Prescription drug · ANDA
Rosuvastatin calcium NDC 68462-264
Rosuvastatin calcium 40 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceutials Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-264-01 | 6846202640168462026401 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-264-01)Marketed from Jul 19, 2016 | |
| 68462-264-05 | 6846202640568462026405 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-264-05)Marketed from Mar 4, 2021 | |
| 68462-264-10 | 6846202641068462026410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-264-10)Marketed from Jul 19, 2016 | |
| 68462-264-30 | 6846202643068462026430 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-264-30)Marketed from Jul 19, 2016 | |
| 68462-264-50 | 6846202645068462026450 | 50 TABLET, FILM COATED in 1 BOTTLE (68462-264-50)Marketed from Jul 19, 2016 | |
| 68462-264-90 | 6846202649068462026490 | 90 TABLET, FILM COATED in 1 BOTTLE (68462-264-90)Marketed from Jul 19, 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 — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Glenmark Pharmaceutials Inc., USANDC labeler code 68462
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079172
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68462-264_760efcac-6dbc-4e58-b2cc-9fc5f9b5603fSPL ID 760efcac-6dbc-4e58-b2cc-9fc5f9b5603fSPL set ID 392657a9-955c-42c2-814c-1890ece45afaRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0368462263907, 0368462261903, 0368462262900, 0368462264300
- 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
N468462026401followed by a unit qualifier and the quantityPackage 68462-0264-01. 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 at increased risk for CV events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): • in adults with hypercholesterolemia. • and slow the progression of atherosclerosis in adults. • in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). • in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). • As an adjunct to diet for the treatm…
Excerpt only. Read the full label for complete information.
About NDC 68462-264
- What is NDC 68462-264?
- 68462-264 is the product NDC for Rosuvastatin calcium, Rosuvastatin calcium 40 mg/1 tablet, film coated, listed with the FDA by Glenmark Pharmaceutials Inc., USA. 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?
- Glenmark Pharmaceutials Inc., USA, NDC labeler code 68462. 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 079172
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 10 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2288 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2289 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-256 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-190 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-309 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-191 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6302 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceutials Inc., USA | 68462-261 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceutials Inc., USA | 68462-262 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceutials Inc., USA | 68462-263 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc., | 68788-8368 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7005 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4143 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4199 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-291 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-458 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3844 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4220 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7973 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7974 |
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