Prescription drug · ANDA
Simvastatin NDC 69367-376
Simvastatin 40 mg/1 · Tablet, Film coated · Oral · Westminster Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69367-376-09 | 69367037609 | 90 TABLET, FILM COATED in 1 BOTTLE (69367-376-09)Marketed from Apr 14, 2025 | |
| 69367-376-10 | 69367037610 | 1000 TABLET, FILM COATED in 1 BOTTLE (69367-376-10)Marketed from Apr 14, 2025 |
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)
- Simvastatin
- Generic name (nonproprietary)
- simvastatin
- Active ingredients
- Simvastatin — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Westminster Pharmaceuticals, LLCNDC labeler code 69367
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211394
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 69367-376_5bcccfd7-0ae8-4fad-a535-5efa7b327550SPL ID 5bcccfd7-0ae8-4fad-a535-5efa7b327550SPL set ID acaaab63-c9ff-44c9-8fde-9a4ea6454dd7RxCUI 198211, 200345, 312961, 314231UNII AGG2FN16EVUPC 0369367374101, 0369367375108, 0369367376105
- 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
N469367037609followed by a unit qualifier and the quantityPackage 69367-0376-09. 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)
Simvastatin is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce LDL-C …
Excerpt only. Read the full label for complete information.
About NDC 69367-376
- What is NDC 69367-376?
- 69367-376 is the product NDC for Simvastatin, Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Westminster Pharmaceuticals, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Simvastatin.
- What is the active ingredient?
- Simvastatin.
- Who is the labeler?
- Westminster Pharmaceuticals, LLC, NDC labeler code 69367. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Simvastatin?
- 155 other product NDCs are listed under this name. See all Simvastatin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Simvastatin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0626 | 67046-0626-03 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0628 | 67046-0628-03 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0542 | 67046-0542-03 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-307 | 72865-0307-0172865-0307-1072865-0307-30+2 more |
| Simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-305 | 72865-0305-0172865-0305-1072865-0305-30+1 more |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-306 | 72865-0306-0172865-0306-1072865-0306-30+1 more |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-308 | 72865-0308-0172865-0308-1072865-0308-30+2 more |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-309 | 72865-0309-0172865-0309-0572865-0309-10+3 more |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-375 | 69367-0375-0969367-0375-10 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-374 | 69367-0374-0969367-0374-10 |
Other NDCs under ANDA 211394
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 |
|---|---|---|---|---|
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-375 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-374 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-377 |