Prescription drug · ANDA
Pravastatin Sodium NDC 0093-0771
Pravastatin sodium 10 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-0771-10 | 00093077110 | 1000 TABLET in 1 BOTTLE (0093-0771-10)Marketed from Mar 7, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076056
- Marketing start
- Marketing end
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 0093-0771_72579e23-23ef-4ab7-ad64-24d5ea7997ebSPL ID 72579e23-23ef-4ab7-ad64-24d5ea7997ebSPL set ID 99e0e848-f8f3-4b42-b880-8fbc42633948RxCUI 904458, 904467, 904475UNII 3M8608UQ61UPC 0300937202981
- 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
N400093077110followed by a unit qualifier and the quantityPackage 00093-0771-10. 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 | 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 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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