Prescription drug · ANDA
Atorvastatin calcium NDC 75834-258
Atorvastatin 80 mg/1 · Tablet · Oral · NIVAGEN PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75834-258-01 | 75834025801 | 1000 TABLET in 1 BOTTLE (75834-258-01)Marketed from Aug 26, 2020 | |
| 75834-258-02 | 75834025802 | 2000 TABLET in 1 BOTTLE (75834-258-02)Marketed from Aug 26, 2020 | |
| 75834-258-50 | 75834025850 | 500 TABLET in 1 BOTTLE (75834-258-50)Marketed from Aug 26, 2020 | |
| 75834-258-90 | 75834025890 | 90 TABLET in 1 BOTTLE (75834-258-90)Marketed from Aug 26, 2020 |
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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- 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 75834-258_4580fe3c-b524-3a14-e063-6294a90a34d3SPL ID 4580fe3c-b524-3a14-e063-6294a90a34d3SPL set ID 7c58bf4a-4a92-4db8-89bc-4de1b5831efcRxCUI 259255, 617310, 617311, 617312UNII A0JWA85V8FUPC 0375834258027, 0375834257501, 0375834255903, 0375834256016
- 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
N475834025801followed by a unit qualifier and the quantityPackage 75834-0258-01. 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)
Atorvastatin calcium tablets is indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years a…
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 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 20 mg/1 | TabletOral | DirectRX | 72189-291 |
| 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 |
- openFDA data updated
Med-Code stores this record for up to 24 hours before requesting it again.
Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.