Prescription drug · ANDA
Atorvastatin Calcium NDC 71335-1011
Atorvastatin calcium trihydrate 40 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1011-1 | 71335101101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1011-1)Marketed from Nov 27, 2018 | |
| 71335-1011-2 | 71335101102 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1011-2)Marketed from May 30, 2024 | |
| 71335-1011-3 | 71335101103 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1011-3)Marketed from Dec 11, 2018 | |
| 71335-1011-4 | 71335101104 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1011-4)Marketed from May 30, 2024 | |
| 71335-1011-5 | 71335101105 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1011-5)Marketed from May 30, 2024 | |
| 71335-1011-6 | 71335101106 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1011-6)Marketed from May 30, 2024 | |
| 71335-1011-7 | 71335101107 | 7 TABLET, FILM COATED in 1 BOTTLE (71335-1011-7)Marketed from May 30, 2024 | |
| 71335-1011-8 | 71335101108 | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1011-8)Marketed from May 30, 2024 |
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 calcium trihydrate — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076477
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1011_ca6cbae0-ba93-4a10-92a5-de9946ffd98eSPL ID ca6cbae0-ba93-4a10-92a5-de9946ffd98eSPL set ID 2e583569-499d-4f20-87ca-84e7d9868d22RxCUI 617311UNII 48A5M73Z4Q
- 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
N471335101101followed by a unit qualifier and the quantityPackage 71335-1011-01. 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 are 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076477
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 calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1710 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-264 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-2824 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1010 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2276 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries Inc. | 63304-829 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries Inc. | 63304-830 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-226 |