Prescription drug · ANDA
Rosuvastatin NDC 11788-131
Rosuvastatin calcium 10 mg/1 · Tablet, Coated · Oral · AiPing Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11788-131-05 | 1178801310511788013105 | 500 TABLET, COATED in 1 BOTTLE (11788-131-05)Marketed from Jan 30, 2026 | |
| 11788-131-10 | 1178801311011788013110 | 1000 TABLET, COATED in 1 BOTTLE (11788-131-10)Marketed from Jan 30, 2026 | |
| 11788-131-90 | 1178801319011788013190 | 90 TABLET, COATED in 1 BOTTLE (11788-131-90)Marketed from Jan 30, 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
- Generic name (nonproprietary)
- rosuvastatin
- Active ingredients
- Rosuvastatin calcium — 10 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- AiPing Pharmaceutical, Inc.NDC labeler code 11788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206513
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 11788-131_42b21540-4538-4c56-adb7-b9cfe8b2b2d5SPL ID 42b21540-4538-4c56-adb7-b9cfe8b2b2d5SPL set ID 913067e8-723b-4ce2-9ebc-3e10b0f0cf7aRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0311788130101, 0311788132907, 0311788130057, 0311788132105, 0311788131900, 0311788132051, 0311788131108, 0311788133904, 0311788131054, 0311788130903, 0311788133058, 0311788133102
- 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
N411788013105followed by a unit qualifier and the quantityPackage 11788-0131-05. 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 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: o Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. o Reduce LDL-C and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hyperch…
Excerpt only. Read the full label for complete information.
About NDC 11788-131
- What is NDC 11788-131?
- 11788-131 is the product NDC for Rosuvastatin, Rosuvastatin calcium 10 mg/1 tablet, coated, listed with the FDA by AiPing Pharmaceutical, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rosuvastatin.
- What is the active ingredient?
- Rosuvastatin calcium.
- Who is the labeler?
- AiPing Pharmaceutical, Inc., NDC labeler code 11788. 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?
- 64 other product NDCs are listed under this name. See all Rosuvastatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rosuvastatin 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 | Rosuvastatin 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4161 | 68788-4161-0368788-4161-0668788-4161-09 |
| Rosuvastatin | Rosuvastatin calcium 5 mg/1 | Tablet, CoatedOral | AiPing Pharmaceutical, Inc. | 11788-130 | 11788-0130-0511788-0130-1011788-0130-90 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, CoatedOral | AiPing Pharmaceutical, Inc. | 11788-132 | 11788-0132-0511788-0132-1011788-0132-90 |
| Rosuvastatin | Rosuvastatin calcium 40 mg/1 | Tablet, CoatedOral | AiPing Pharmaceutical, Inc. | 11788-133 | 11788-0133-0511788-0133-1011788-0133-90 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1627 | 67046-1627-03 |
| Rosuvastatin | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-189 | 82009-0189-05 |
| Rosuvastatin | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-188 | 82009-0188-05 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-190 | 82009-0190-05 |
| Rosuvastatin | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-191 | 82009-0191-05 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4057 | 68788-4057-0268788-4057-0368788-4057-06+1 more |
Other NDCs under ANDA 206513
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 | Rosuvastatin calcium 5 mg/1 | Tablet, CoatedOral | AiPing Pharmaceutical, Inc. | 11788-130 |
| Rosuvastatin | Rosuvastatin calcium 20 mg/1 | Tablet, CoatedOral | AiPing Pharmaceutical, Inc. | 11788-132 |
| Rosuvastatin | Rosuvastatin calcium 40 mg/1 | Tablet, CoatedOral | AiPing Pharmaceutical, Inc. | 11788-133 |