Prescription drug · ANDA
Atorvastatin calcium NDC 82804-056
Atorvastatin 40 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-056-30 | 82804005630 | 30 TABLET in 1 BOTTLE (82804-056-30)Marketed from Jan 12, 2024 | |
| 82804-056-60 | 82804005660 | 60 TABLET in 1 BOTTLE (82804-056-60)Marketed from Jan 12, 2024 | |
| 82804-056-90 | 82804005690 | 90 TABLET in 1 BOTTLE (82804-056-90)Marketed from Jan 12, 2024 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 82804-056_acbbd2c4-60bd-4e01-ad7a-b9b3178569f0SPL ID acbbd2c4-60bd-4e01-ad7a-b9b3178569f0SPL set ID acbbd2c4-60bd-4e01-ad7a-b9b3178569f0RxCUI 617311UNII A0JWA85V8FUPC 0382804056309
- 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
N482804005630followed by a unit qualifier and the quantityPackage 82804-0056-30. 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)
Atorvastatin calcium tablets is indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o 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: o Adults with primary hyperlipidemia. o Adults and pediatric patients 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 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 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 |