Prescription drug · ANDA
Pravastatin Sodium NDC 71335-2253
Pravastatin sodium 80 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2253-1 | 7133522530171335225301 | 30 TABLET in 1 BOTTLE (71335-2253-1)Marketed from Jan 31, 2025 | |
| 71335-2253-2 | 7133522530271335225302 | 90 TABLET in 1 BOTTLE (71335-2253-2)Marketed from Jan 31, 2025 | |
| 71335-2253-3 | 7133522530371335225303 | 58 TABLET in 1 BOTTLE (71335-2253-3)Marketed from Jan 31, 2025 | |
| 71335-2253-4 | 7133522530471335225304 | 88 TABLET in 1 BOTTLE (71335-2253-4)Marketed from Jan 31, 2025 | |
| 71335-2253-5 | 7133522530571335225305 | 10 TABLET in 1 BOTTLE (71335-2253-5)Marketed from Jan 31, 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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-2253_198579ff-220c-4491-8968-73f695a82b09SPL ID 198579ff-220c-4491-8968-73f695a82b09SPL set ID c0b1b483-1a19-4966-89b1-118ec660f203RxCUI 904481UNII 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
N471335225301followed by a unit qualifier and the quantityPackage 71335-2253-01. 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.
About NDC 71335-2253
- What is NDC 71335-2253?
- 71335-2253 is the product NDC for Pravastatin Sodium, Pravastatin sodium 80 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pravastatin Sodium.
- What is the active ingredient?
- Pravastatin sodium.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 60 mg/1 | TabletOral | Havix Group Inc d-b-a Aavis Pharmaceuticals | 71337-290 | 71337-0290-09 |
| 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 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-167 | 84386-0167-9084386-0167-99 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-103 | 69292-0103-1069292-0103-5069292-0103-90 |
| 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 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 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 40 mg/1 | TabletOral | Quallent | 82009-007 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Apotex Corp. | 60505-1323 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Quallent | 82009-006 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5892 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Quallent | 82009-008 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0692 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5893 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7275 |
| 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 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Proficient Rx LP | 71205-516 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8833 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-143 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-976 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8835 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-1938 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8836 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-161 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0549 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-6826 |
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