Prescription drug · ANDA
Pravastatin Sodium NDC 71205-294
Pravastatin sodium 40 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-294-30 | 71205029430 | 30 TABLET in 1 BOTTLE (71205-294-30)Marketed from Jul 1, 2019 | |
| 71205-294-60 | 71205029460 | 60 TABLET in 1 BOTTLE (71205-294-60)Marketed from Jul 1, 2019 | |
| 71205-294-90 | 71205029490 | 90 TABLET in 1 BOTTLE (71205-294-90)Marketed from Jul 1, 2019 |
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)
- Pravastatin Sodium
- Generic name (nonproprietary)
- pravastatin sodium
- Active ingredients
- Pravastatin sodium — 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 076056
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-294_e33be6df-cf54-48ba-b407-16b7b311fdb8SPL ID e33be6df-cf54-48ba-b407-16b7b311fdb8SPL set ID 466e2d1a-a6d6-40f8-a9f6-3e7494a34ca6RxCUI 904475UNII 3M8608UQ61UPC 0371205294304
- 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
N471205029430followed by a unit qualifier and the quantityPackage 71205-0294-30. 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)
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: • Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. ( 1.1 ) • Reduce the risk of total mortality by…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076056
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 |
|---|---|---|---|---|
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7948 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3895 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7947 |
| Pravastatin sodium | Pravastatin sodium 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-031 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-032 |
| Pravastatin sodium | Pravastatin sodium 40 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-033 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-0973 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8871 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7201 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4049 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-7202 |
| Pravastatin sodium | Pravastatin sodium 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4059 |
| Pravastatin sodium | Pravastatin sodium 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4339 |
| Pravastatin sodium | Pravastatin sodium 40 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-096 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6898 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0093-0771 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-343 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3788 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4408 |
| Pravastatin sodium | Pravastatin sodium 40 mg/1 | TabletOral | Safecor Health LLC | 48433-149 |
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