Prescription drug · ANDA
Atorvastatin Calcium NDC 63187-907
Atorvastatin calcium trihydrate 80 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-907-30 | 63187090730 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-907-30)Marketed from Sep 1, 2017 | |
| 63187-907-60 | 63187090760 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-907-60)Marketed from Sep 1, 2017 | |
| 63187-907-90 | 63187090790 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-907-90)Marketed from Sep 1, 2017 |
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 trihydrate — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205519
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 63187-907_6fe42517-aec2-4203-9574-2576c6472a94SPL ID 6fe42517-aec2-4203-9574-2576c6472a94SPL set ID a34d3c72-ce91-47c7-86a1-f32caaed2c47RxCUI 259255UNII 48A5M73Z4QUPC 0363187907907
- 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
N463187090730followed by a unit qualifier and the quantityPackage 63187-0907-30. 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 tablet is an inhibitor of HMG-CoA reductase (statin) indicated as an adjunct therapy to diet to: • Reduce the risk of MI, stroke, revascularization procedu…
Excerpt only. Read the full label for complete information.
About NDC 63187-907
- What is NDC 63187-907?
- 63187-907 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 80 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atorvastatin Calcium.
- What is the active ingredient?
- Atorvastatin calcium trihydrate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atorvastatin Calcium?
- 385 other product NDCs are listed under this name. See all Atorvastatin Calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atorvastatin Calcium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0284 | 55154-0284-06 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-681 | 72189-0681-30 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3585 | 00480-3585-1000480-3585-98 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-013 | 87441-0013-01 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3586 | 00480-3586-1000480-3586-98 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3587 | 00480-3587-1000480-3587-98 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1677 | 67046-1677-03 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3588 | 00480-3588-1000480-3588-98 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1666 | 67046-1666-03 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4592 | 70518-4592-00 |
Other NDCs under ANDA 205519
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 | 72162-1554 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1555 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1556 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-454 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-944 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-451 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-452 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-453 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-945 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-946 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-947 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals, Inc. | 77771-451 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals, Inc. | 77771-452 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals, Inc. | 77771-453 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Radha Pharmaceuticals, Inc. | 77771-454 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-745 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-744 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-746 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8469 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8472 |
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