Prescription drug · ANDA
Pravastatin Sodium NDC 61919-708
Pravastatin sodium 40 mg/1 · Tablet · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61919-708-30 | 61919070830 | 30 TABLET in 1 BOTTLE (61919-708-30)Marketed from Jan 15, 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
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207068
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 61919-708_0e994ad4-d03f-9670-e063-6294a90adad3SPL ID 0e994ad4-d03f-9670-e063-6294a90adad3SPL set ID 7f814fd9-7b35-67da-e053-2a91aa0a39dcRxCUI 904467, 904475UNII 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
N461919070830followed by a unit qualifier and the quantityPackage 61919-0708-30. 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. 1.1 Prevention of Cardiovascular Disease In hypercholesterolemic patients without clinically evident coronary heart disease (CHD), pravastatin sodium tablets are indicated to: reduce the risk of myocardial infarction (MI). reduce the risk of undergoing myocardial revascularization procedures. reduce th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207068
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 | PD-Rx Pharmaceuticals, Inc. | 43063-807 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-808 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Proficient Rx LP | 71205-121 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-011 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-008 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-009 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-010 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0296 |