Prescription drug · ANDA
Rosuvastatin NDC 68788-4161
Rosuvastatin 5 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4161-3 | 6878841610368788416103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4161-3)Marketed from Jul 22, 2026 | |
| 68788-4161-6 | 6878841610668788416106 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-4161-6)Marketed from Jul 22, 2026 | |
| 68788-4161-9 | 6878841610968788416109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-4161-9)Marketed from Jul 22, 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
- Generic name (nonproprietary)
- rosuvastatin
- Active ingredients
- Rosuvastatin — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206381
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-4161_88fd44de-f2c4-4541-a859-bb9553da9674SPL ID 88fd44de-f2c4-4541-a859-bb9553da9674SPL set ID 88fd44de-f2c4-4541-a859-bb9553da9674RxCUI 859424UNII 413KH5ZJ73
- 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
N468788416103followed by a unit qualifier and the quantityPackage 68788-4161-03. 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 hyp…
Excerpt only. Read the full label for complete information.
About NDC 68788-4161
- What is NDC 68788-4161?
- 68788-4161 is the product NDC for Rosuvastatin, Rosuvastatin 5 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals 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.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 calcium 5 mg/1 | Tablet, CoatedOral | AiPing Pharmaceutical, Inc. | 11788-130 | 11788-0130-0511788-0130-1011788-0130-90 |
| Rosuvastatin | Rosuvastatin calcium 10 mg/1 | Tablet, CoatedOral | AiPing Pharmaceutical, Inc. | 11788-131 | 11788-0131-0511788-0131-1011788-0131-90 |
| 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 206381
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 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-922 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2539 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3847 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7431 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-118 |
| Rosuvastatin | Rosuvastatin 5 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-116 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-117 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-119 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7730 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7482 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7483 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4296 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4303 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-796 |
| Rosuvastatin | Rosuvastatin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7241 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4314 |
| Rosuvastatin | Rosuvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-797 |
| Rosuvastatin | Rosuvastatin 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7240 |
| Rosuvastatin | Rosuvastatin 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-798 |
| Rosuvastatin | Rosuvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7793 |
Showing 20 of 32.