Prescription drug · ANDA
Atorvastatin calcium NDC 70518-3848
Atorvastatin 80 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3848-0 | 70518384800 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3848-0)Marketed from Aug 31, 2023 | |
| 70518-3848-2 | 70518384802 | 100 TABLET in 1 BOTTLE, PLASTIC (70518-3848-2)Marketed from Mar 19, 2025 |
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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- 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 70518-3848_53d52358-aa1b-cc96-e063-6294a90a81fbSPL ID 53d52358-aa1b-cc96-e063-6294a90a81fbSPL set ID 6600f22e-d303-4fe3-8212-accd6fb06e62RxCUI 259255UNII 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
N470518384800followed by a unit qualifier and the quantityPackage 70518-3848-00. 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 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 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 |