Prescription drug · ANDA
Rosuvastatin Calcium NDC 69434-007
Rosuvastatin calcium 20 mg/1 · Tablet, Film coated · Oral · Zhejiang Yongtai Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69434-007-02 | 69434000702 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-007-02)Marketed from Aug 1, 2026 | |
| 69434-007-03 | 69434000703 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-007-03)Marketed from Aug 1, 2026 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212059
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 69434-007_f378d351-0576-4496-baca-a2858712bc5cSPL ID f378d351-0576-4496-baca-a2858712bc5cSPL set ID 40c2900e-4659-49ce-ba4b-5df529b3c53bRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0369434006027, 0369434008014
- 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
N469434000702followed by a unit qualifier and the quantityPackage 69434-0007-02. 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.
Other NDCs under ANDA 212059
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 | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-005 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-006 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-008 |