Prescription drug · ANDA
Pravastatin Sodium NDC 68180-485
Pravastatin sodium 10 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Pravastatin Sodium
- Generic name (nonproprietary)
- pravastatin sodium
- Active ingredients
- Pravastatin sodium — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077917
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68180-485_a173dd76-57cb-4066-a51f-26adfb79e861SPL ID a173dd76-57cb-4066-a51f-26adfb79e861SPL set ID 1123d56c-16f0-4f81-b56f-67b1f343ae1eRxCUI 904458, 904467, 904475, 904481UNII 3M8608UQ61UPC 0368180487098
- 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Pravastatin sodium tablets are an HMG-CoA reductase inhibitor (statin) indicated ( 1 ): To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated lowdensity 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 …
Excerpt only. Read the full label for complete information.
About NDC 68180-485
- What is NDC 68180-485?
- 68180-485 is the product NDC for Pravastatin Sodium, Pravastatin sodium 10 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Pravastatin Sodium.
- What is the active ingredient?
- Pravastatin sodium.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pravastatin Sodium?
- 184 other product NDCs are listed under this name. See all Pravastatin Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pravastatin Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pravastatin Sodium | Pravastatin sodium 30 mg/1 | TabletOral | Havix Group Inc d-b-a Aavis Pharmaceuticals | 71337-289 | 71337-0289-09 |
| Pravastatin Sodium | Pravastatin sodium 60 mg/1 | TabletOral | Havix Group Inc d-b-a Aavis Pharmaceuticals | 71337-290 | 71337-0290-09 |
| Pravastatin sodium | Pravastatin sodium 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-167 | 84386-0167-9084386-0167-99 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-101 | 69292-0101-1069292-0101-5069292-0101-90 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-102 | 69292-0102-1069292-0102-5069292-0102-90 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-103 | 69292-0103-1069292-0103-5069292-0103-90 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-104 | 69292-0104-1069292-0104-5069292-0104-90 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-104 | 82868-0104-30 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | Safecor Health LLC | 48433-148 | 48433-0148-20 |
| Pravastatin sodium | Pravastatin sodium 40 mg/1 | TabletOral | Safecor Health LLC | 48433-149 | 48433-0149-20 |
Other NDCs under ANDA 077917
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 10 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-847 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-848 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-849 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-850 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-486 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-487 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-488 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0947 |