Prescription drug · ANDA
Atorvastatin Calcium NDC 63187-108
Atorvastatin calcium propylene glycol solvate 20 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-108-30 | 63187010830 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-108-30)Marketed from Aug 1, 2015 | |
| 63187-108-60 | 63187010860 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-108-60)Marketed from Aug 1, 2015 | |
| 63187-108-90 | 63187010890 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-108-90)Marketed from Aug 1, 2015 |
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)
- Atorvastatin Calcium
- Generic name (nonproprietary)
- atorvastatin calcium
- Active ingredients
- Atorvastatin calcium propylene glycol solvate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090548
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-108_12381014-c129-45f9-b594-44c8d1d3cd11SPL ID 12381014-c129-45f9-b594-44c8d1d3cd11SPL set ID 44f0df8b-6069-4941-87e9-2c57c8dfddfaRxCUI 617310, 617311UNII YRZ789OWMIUPC 0363187109301, 0363187108304
- 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
N463187010830followed by a unit qualifier and the quantityPackage 63187-0108-30. 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 tablets are an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to: • Reduce the risk of MI, stroke, revascularization proce…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090548
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 propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-2580 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6293 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-2671 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-656 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-2018 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-022 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-013 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4166 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6440 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6441 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-176 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1051 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-173 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-175 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-590 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-029 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-613 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6479 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6480 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6481 |
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