Prescription drug · ANDA
Atorvastatin Calcium NDC 72189-291
Atorvastatin 20 mg/1 · Tablet · Oral · DirectRX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-291-90 | 72189029190 | 90 TABLET in 1 BOTTLE (72189-291-90)Marketed from Nov 10, 2021 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- DirectRX
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213853
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-291_2c2947eb-f8b1-c0f8-e063-6394a90aa6f0SPL ID 2c2947eb-f8b1-c0f8-e063-6394a90aa6f0SPL set ID d076309f-313a-1c71-e053-2995a90a7bb7RxCUI 617310UNII A0JWA85V8F
- 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
N472189029190followed by a unit qualifier and the quantityPackage 72189-0291-90. 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. 1.1 Prevention of Cardiovascular Disease in Adults In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart diseas…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213853
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 20 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-256 |
| Atorvastatin calcium | Atorvastatin 40 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-257 |
| Atorvastatin calcium | Atorvastatin 80 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-258 |
| Atorvastatin calcium | Atorvastatin 20 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2967 |
| Atorvastatin calcium | Atorvastatin 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3783 |
| Atorvastatin calcium | Atorvastatin 10 mg/1 | TabletOral | NIVAGEN PHARMACEUTICALS, INC. | 75834-255 |
| Atorvastatin calcium | Atorvastatin 80 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3848 |
| Atorvastatin calcium | Atorvastatin 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2697 |
| Atorvastatin calcium | Atorvastatin 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4321 |
| Atorvastatin calcium | Atorvastatin 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9646 |
| Atorvastatin calcium | Atorvastatin 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2213 |
| Atorvastatin Calcium | Atorvastatin 10 mg/1 | TabletOral | Direct_Rx | 72189-531 |
| Atorvastatin calcium | Atorvastatin 40 mg/1 | TabletOral | Proficient Rx LP | 82804-056 |
| Atorvastatin calcium | Atorvastatin 20 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-040 |
| Atorvastatin calcium | Atorvastatin 10 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-039 |
| Atorvastatin calcium | Atorvastatin 80 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-042 |
| Atorvastatin calcium | Atorvastatin 40 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-041 |