Prescription drug · ANDA
Pravastatin Sodium NDC 71335-1022
Pravastatin sodium 20 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1022-1 | 71335102201 | 30 TABLET in 1 BOTTLE (71335-1022-1)Marketed from Jan 14, 2019 | |
| 71335-1022-2 | 71335102202 | 90 TABLET in 1 BOTTLE (71335-1022-2)Marketed from Dec 7, 2018 | |
| 71335-1022-3 | 71335102203 | 100 TABLET in 1 BOTTLE (71335-1022-3)Marketed from Jan 29, 2025 | |
| 71335-1022-4 | 71335102204 | 60 TABLET in 1 BOTTLE (71335-1022-4)Marketed from Jan 29, 2025 | |
| 71335-1022-5 | 71335102205 | 10 TABLET in 1 BOTTLE (71335-1022-5)Marketed from Jan 29, 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 — 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 076341
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1022_5936185f-946b-4158-9902-6f3288c958faSPL ID 5936185f-946b-4158-9902-6f3288c958faSPL set ID 8d1bf7a5-bf11-47e3-afca-dcc13f2d3068RxCUI 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
N471335102201followed by a unit qualifier and the quantityPackage 71335-1022-01. 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 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 076341
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 | REMEDYREPACK INC. | 70518-1938 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8618 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7998 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-976 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8833 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8835 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8836 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0549 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8619 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7009 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5891 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8620 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5892 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-3204 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8621 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | DIRECT RX | 72189-119 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0876 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2908 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-2024 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-2025 |
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