Prescription drug · ANDA
Pravastatin sodium NDC 84386-167
Pravastatin sodium 80 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84386-167-90 | 8438601679084386016790 | 90 TABLET in 1 BOTTLE (84386-167-90)Marketed from Sep 4, 2026 | |
| 84386-167-99 | 8438601679984386016799 | 1000 TABLET in 1 BOTTLE (84386-167-99)Marketed from Sep 4, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 84386
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077793
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 84386-167_42ccbca7-fa52-4df9-8f1a-ea7da7312883SPL ID 42ccbca7-fa52-4df9-8f1a-ea7da7312883
- 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
N484386016790followed by a unit qualifier and the quantityPackage 84386-0167-90. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 84386-167
- What is NDC 84386-167?
- 84386-167 is the product NDC for Pravastatin sodium, Pravastatin sodium 80 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 2 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?
- Aurobindo Pharma Limited, NDC labeler code 84386. 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?
- 183 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 20 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-102 | 69292-0102-1069292-0102-5069292-0102-90 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Amici Pharma, Inc. | 69292-101 | 69292-0101-1069292-0101-5069292-0101-90 |
| Pravastatin Sodium | Pravastatin sodium 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 40 mg/1 | TabletOral | Safecor Health LLC | 48433-149 | 48433-0149-20 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | Safecor Health LLC | 48433-148 | 48433-0148-20 |
| Pravastatin sodium | Pravastatin sodium 40 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-096 | 82868-0096-30 |
| Pravastatin sodium | Pravastatin sodium 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4059 | 68788-4059-0368788-4059-0668788-4059-09 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Coupler LLC | 67046-1621 | 67046-1621-03 |
Other NDCs under ANDA 077793
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 80 mg/1 | TabletOral | Teva Pharmaceuticals, Inc. | 0480-7270 |
| Pravastatin sodium | Pravastatin sodium 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-034 |