Prescription drug · ANDA
Pravastatin Sodium NDC 71335-0947
Pravastatin sodium 20 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0947-1 | 71335094701 | 30 TABLET in 1 BOTTLE (71335-0947-1)Marketed from Sep 23, 2022 | |
| 71335-0947-2 | 71335094702 | 90 TABLET in 1 BOTTLE (71335-0947-2)Marketed from Sep 4, 2018 | |
| 71335-0947-3 | 71335094703 | 100 TABLET in 1 BOTTLE (71335-0947-3)Marketed from Sep 23, 2022 | |
| 71335-0947-4 | 71335094704 | 60 TABLET in 1 BOTTLE (71335-0947-4)Marketed from Sep 23, 2022 | |
| 71335-0947-5 | 71335094705 | 10 TABLET in 1 BOTTLE (71335-0947-5)Marketed from Sep 23, 2022 |
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 — 20 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 077917
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0947_eaf669a7-a5e3-4241-aed5-f696283508e6SPL ID eaf669a7-a5e3-4241-aed5-f696283508e6SPL set ID 24471777-5cd6-4c46-a5f2-a349fadc830eRxCUI 904467UNII 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
N471335094701followed by a unit qualifier and the quantityPackage 71335-0947-01. 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)
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.
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 20 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-848 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | Tablet, Film coatedOral | Chartwell RX, LLC | 62135-847 |
| 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 10 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-485 |
| 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 |