Prescription drug · ANDA
Pravastatin sodium NDC 55111-274
Pravastatin sodium 80 mg/1 · Tablet · Oral · Dr.Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-274-01 | 5511102740155111027401 | 100 TABLET in 1 BOTTLE (55111-274-01)Marketed from Dec 31, 2009 | |
| 55111-274-05 | 5511102740555111027405 | 500 TABLET in 1 BOTTLE (55111-274-05)Marketed from Dec 31, 2009 | |
| 55111-274-30 | 5511102743055111027430 | 30 TABLET in 1 BOTTLE (55111-274-30)Marketed from Dec 31, 2009 | |
| 55111-274-90 | 5511102749055111027490 | 90 TABLET in 1 BOTTLE (55111-274-90)Marketed from Dec 31, 2009 |
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
- Dr.Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076714
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 55111-274_5f4e21ff-4bcc-df0d-a629-ba190d95edc0SPL ID 5f4e21ff-4bcc-df0d-a629-ba190d95edc0SPL set ID 99cc0546-bb2d-751e-edfd-1c15a1182e0cRxCUI 904458, 904467, 904475, 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
N455111027401followed by a unit qualifier and the quantityPackage 55111-0274-01. 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)
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Pravastatin sodium is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce the risk of MI,revascularization, andcardiovascularmortalityin hypercholesterolemicpatientswithout clinicallyevidentCHD. (1.1) Reduce the risk of total mortality by reducing coronary deat…
Excerpt only. Read the full label for complete information.
About NDC 55111-274
- What is NDC 55111-274?
- 55111-274 is the product NDC for Pravastatin sodium, Pravastatin sodium 80 mg/1 tablet, listed with the FDA by Dr.Reddy's Laboratories Limited. It has 4 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?
- Dr.Reddy's Laboratories Limited, NDC labeler code 55111. 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 076714
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 | Dr.Reddy's Laboratories Limited | 55111-229 |
| Pravastatin sodium | Pravastatin sodium 20 mg/1 | TabletOral | Dr.Reddy's Laboratories Limited | 55111-230 |
| Pravastatin sodium | Pravastatin sodium 40 mg/1 | TabletOral | Dr.Reddy's Laboratories Limited | 55111-231 |