Prescription drug · ANDA
Atorvastatin Calcium NDC 71335-2388
atorvastatin calcium, film coated · Atorvastatin calcium trihydrate 10 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2388-1 | 71335238801 | 30 TABLET in 1 BOTTLE (71335-2388-1)Marketed from May 29, 2024 | |
| 71335-2388-2 | 71335238802 | 90 TABLET in 1 BOTTLE (71335-2388-2)Marketed from May 29, 2024 | |
| 71335-2388-3 | 71335238803 | 60 TABLET in 1 BOTTLE (71335-2388-3)Marketed from May 29, 2024 | |
| 71335-2388-4 | 71335238804 | 120 TABLET in 1 BOTTLE (71335-2388-4)Marketed from May 29, 2024 | |
| 71335-2388-5 | 71335238805 | 100 TABLET in 1 BOTTLE (71335-2388-5)Marketed from May 29, 2024 | |
| 71335-2388-6 | 71335238806 | 180 TABLET in 1 BOTTLE (71335-2388-6)Marketed from May 29, 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, film coated
- Active ingredients
- Atorvastatin calcium trihydrate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209912
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-2388_351d59d0-e7fd-a0c6-e063-6394a90ab9baSPL ID 351d59d0-e7fd-a0c6-e063-6394a90ab9baSPL set ID b8fa04f5-0d56-49ca-bb01-f0dd3b472164RxCUI 617312UNII 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
N471335238801followed by a unit qualifier and the quantityPackage 71335-2388-01. 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: ○ 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209912
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 Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2591 |
| atorvastatin calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3546 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2582 |
| atorvastatin calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2994 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3868 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3882 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3891 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-136 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2404 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 80 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-139 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-137 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-138 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3912 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8842 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8887 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8693 |