Prescription drug · ANDA
Pravastatin Sodium NDC 63629-8913
Pravastatin sodium 80 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8913-1 | 63629891301 | 500 TABLET in 1 BOTTLE (63629-8913-1)Marketed from Nov 19, 2021 |
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)
- Pravastatin Sodium
- Generic name (nonproprietary)
- pravastatin sodium
- Active ingredients
- Pravastatin sodium — 80 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 209869
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-8913_337944c8-5831-8ba0-e063-6294a90a5989SPL ID 337944c8-5831-8ba0-e063-6294a90a5989SPL set ID 80ddec55-6a18-4b87-8a07-6ae86ad62853RxCUI 904481UNII 3M8608UQ61
- 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
N463629891301followed by a unit qualifier and the quantityPackage 63629-8913-01. 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)
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 is 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 reducing coron…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209869
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 40 mg/1 | TabletOral | Biocon Pharma Inc. | 70377-047 |
| Pravastatin sodium | Pravastatin sodium 10 mg/1 | TabletOral | Biocon Pharma Inc. | 70377-045 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | Biocon Pharma Inc. | 70377-046 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7892 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7893 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8906 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8904 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8909 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8910 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8911 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8912 |
| Pravastatin sodium | Pravastatin sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2687 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9164 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9162 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9163 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-9165 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1951 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1953 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-877 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-884 |
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