Prescription drug · ANDA
Rosuvastatin calcium NDC 72303-0829
Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · HEC Pharm USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72303-0829-1 | 72303082901 | 90 TABLET, FILM COATED in 1 BOTTLE (72303-0829-1)Marketed from Jul 1, 2026 |
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 — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- HEC Pharm USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210667
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 72303-0829_57a6409f-9fd1-54ae-e063-6294a90ae490SPL ID 57a6409f-9fd1-54ae-e063-6294a90ae490SPL set ID 568a782b-1621-5e59-e063-6294a90a7fefRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0372303082817, 0372303082718, 0372303083012, 0372303082916
- 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
N472303082901followed by a unit qualifier and the quantityPackage 72303-0829-01. 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): 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 hypercholesterolemia (HoFH). As an adjunct to diet for the trea…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210667
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 | HEC Pharm USA Inc. | 72303-0828 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0827 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0830 |