Prescription drug · ANDA
Pravastatin sodium NDC 70518-4339
Pravastatin sodium 40 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4339-0 | 70518433900 | 30 TABLET in 1 BLISTER PACK (70518-4339-0)Marketed from May 13, 2025 | |
| 70518-4339-1 | 70518433901 | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4339-1)Marketed from Aug 25, 2025 |
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 — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- 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 70518-4339_5aae136b-3dd2-fe0c-e063-6294a90a868dSPL ID 5aae136b-3dd2-fe0c-e063-6294a90a868dSPL set ID fa152ce7-6c07-4aaf-9374-932ce81d0cf9RxCUI 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
N470518433900followed by a unit qualifier and the quantityPackage 70518-4339-00. 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)
Pravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial …
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 | 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 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-4206 |
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