Prescription drug · ANDA
Atorvastatin Calcium NDC 68071-2389
Atorvastatin calcium trihydrate 10 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2389-3 | 68071238903 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-2389-3)Marketed from Apr 22, 2021 | |
| 68071-2389-6 | 68071238906 | 60 TABLET, FILM COATED in 1 BOTTLE (68071-2389-6)Marketed from Apr 22, 2021 |
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)
- Atorvastatin Calcium
- Generic name (nonproprietary)
- atorvastatin calcium
- Active ingredients
- Atorvastatin calcium trihydrate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207687
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-2389_4c5014c9-e8b8-a0bb-e063-6394a90a9d10SPL ID 4c5014c9-e8b8-a0bb-e063-6394a90a9d10SPL set ID c095d497-0634-6413-e053-2a95a90aa67fRxCUI 617312UNII 48A5M73Z4QUPC 0368071238938
- 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
N468071238903followed by a unit qualifier and the quantityPackage 68071-2389-03. 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)
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, atorvastatin calcium tablets can be started simultaneously with diet. Atorvastatin calcium is an HMG-CoA reductase inhibitor indicated as an adjunct therapy to diet to: Reduce the risk of MI, stroke, revascularization procedures, and angina in ad…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207687
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 |
|---|---|---|---|---|
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1388 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5168 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5194 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5198 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1507 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1126 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-731 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-046 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-044 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-045 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Accord Healthcare Inc. | 16729-047 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-246 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-247 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-946 |