Prescription drug · NDA
Lipitor (Atorvastatin calcium) NDC 58151-158
Atorvastatin calcium trihydrate 80 mg/1 · Tablet, Film coated · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-158-77 | 58151015877 | 90 TABLET, FILM COATED in 1 BOTTLE (58151-158-77)Marketed from Feb 29, 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)
- Lipitor
- Generic name (nonproprietary)
- atorvastatin calcium
- Active ingredients
- Atorvastatin calcium trihydrate — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020702
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 58151-158_dd011a82-7356-4b83-86c4-b21cd9138fc6SPL ID dd011a82-7356-4b83-86c4-b21cd9138fc6SPL set ID a60cc18b-0631-4cf0-b021-9f52224ece65RxCUI 259255, 262095, 617310, 617311, 617312, 617314, 617318, 617320UNII 48A5M73Z4QUPC 0358151155774, 0358151156771, 0358151158775, 0358151157778
- 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
N458151015877followed by a unit qualifier and the quantityPackage 58151-0158-77. 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)
LIPITOR 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 aged 10 years and olde…
Excerpt only. Read the full label for complete information.
About NDC 58151-158
- What is NDC 58151-158?
- 58151-158 is the product NDC for Lipitor (atorvastatin calcium), Atorvastatin calcium trihydrate 80 mg/1 tablet, film coated, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lipitor (Atorvastatin calcium).
- What is the active ingredient?
- Atorvastatin calcium trihydrate.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lipitor?
- 3 other product NDCs are listed under this name. See all Lipitor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lipitor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lipitoratorvastatin calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-155 | 58151-0155-77 |
| Lipitoratorvastatin calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-156 | 58151-0156-77 |
| Lipitoratorvastatin calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-157 | 58151-0157-77 |
Other NDCs under NDA 020702
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 |
|---|---|---|---|---|
| Lipitoratorvastatin calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-155 |
| Lipitoratorvastatin calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-156 |
| Lipitoratorvastatin calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-157 |