Prescription drug · ANDA
Pravastatin Sodium NDC 68788-8425
Pravastatin sodium 10 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8425-3 | 6878884250368788842503 | 30 TABLET in 1 BOTTLE (68788-8425-3)Marketed from Apr 17, 2023 | |
| 68788-8425-6 | 6878884250668788842506 | 60 TABLET in 1 BOTTLE (68788-8425-6)Marketed from Apr 17, 2023 | |
| 68788-8425-9 | 6878884250968788842509 | 90 TABLET in 1 BOTTLE (68788-8425-9)Marketed from Apr 17, 2023 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077987
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-8425_7d022e1b-2ce1-4a1b-b83d-2db86b48b264SPL ID 7d022e1b-2ce1-4a1b-b83d-2db86b48b264SPL set ID 095ac6fd-fdfb-4207-b15d-8e93bee378c3RxCUI 904458, 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
N468788842503followed by a unit qualifier and the quantityPackage 68788-8425-03. 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: 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 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 …
Excerpt only. Read the full label for complete information.
About NDC 68788-8425
- What is NDC 68788-8425?
- 68788-8425 is the product NDC for Pravastatin Sodium, Pravastatin sodium 10 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 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?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 077987
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 | A-S Medication Solutions | 50090-1533 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-1594 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-5809 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8421 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7709 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-0975 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7710 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | American Health Packaging | 60687-886 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | CIPLA USA INC. | 69097-788 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | CIPLA USA INC. | 69097-789 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | CIPLA USA INC. | 69097-791 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | CIPLA USA INC. | 69097-792 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8540 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | American Health Packaging | 60687-897 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Coupler LLC | 67046-1518 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Coupler LLC | 67046-1519 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | American Health Packaging | 60687-908 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8541 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8542 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-594 |
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