Prescription drug · ANDA
Pravastatin Sodium NDC 35356-919
Pravastatin sodium 20 mg/1 · Tablet · Oral · Lake Erie Medical DBA Quality Care Products LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35356-919-30 | 3535609193035356091930 | 30 TABLET in 1 BOTTLE (35356-919-30)Marketed from Jul 18, 2011 | |
| 35356-919-90 | 3535609199035356091990 | 90 TABLET in 1 BOTTLE (35356-919-90)Marketed from Jul 18, 2011 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lake Erie Medical DBA Quality Care Products LLCNDC labeler code 35356
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076341
- Marketing start
- Marketing end
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 35356-919_77f23591-e677-43b5-8ed8-47059fc8ed3fSPL ID 77f23591-e677-43b5-8ed8-47059fc8ed3fSPL set ID e7194af1-6304-4e3e-88ab-0825706a3962RxCUI 904458, 904467, 904475UNII 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
N435356091930followed by a unit qualifier and the quantityPackage 35356-0919-30. 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)
INDICATIONS AND USAGE Therapy with Pravastatin Sodium Tablets, USP should be considered in those individuals at increased risk for atherosclerosis-related clinical events as a function of cholesterol level, the presence or absence of coronary heart disease, and other risk factors. Primary Prevention of Coronary Events In hypercholesterolemic patients without clinically evident coronary heart disease, Pravastatin Sodium Tablets, USP are indicated to: Reduce the risk of myocardial infarction Reduce the risk of undergoing myocardial revascularization procedures Reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. Hyperlipidemia Pravastatin Sodium…
Excerpt only. Read the full label for complete information.
About NDC 35356-919
- What is NDC 35356-919?
- 35356-919 is the product NDC for Pravastatin Sodium, Pravastatin sodium 20 mg/1 tablet, listed with the FDA by Lake Erie Medical DBA Quality Care Products LLC. 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?
- Lake Erie Medical DBA Quality Care Products LLC, NDC labeler code 35356. 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 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 10 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8618 |
| 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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8620 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8621 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5891 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5892 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Major Pharmaceuticals | 0904-5893 |
| 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 80 mg/1 | TabletOral | A-S Medication Solutions | 50090-3204 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-3853 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | A-S Medication Solutions | 50090-6826 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-7813 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | AvPAK | 50268-665 |
| Pravastatin Sodium | Pravastatin sodium 20 mg/1 | TabletOral | AvPAK | 50268-666 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | AvPAK | 50268-667 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | AvPAK | 50268-668 |
| Pravastatin Sodium | Pravastatin sodium 40 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-708 |
| Pravastatin Sodium | Pravastatin sodium 80 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-976 |
| Pravastatin Sodium | Pravastatin sodium 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-3350 |
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