Prescription drug · ANDA
Simvastatin NDC 68788-8369
Simvastatin 10 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8369-1 | 68788836901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8369-1)Marketed from Feb 1, 2023 | |
| 68788-8369-3 | 68788836903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8369-3)Marketed from Feb 1, 2023 | |
| 68788-8369-6 | 68788836906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8369-6)Marketed from Feb 1, 2023 | |
| 68788-8369-9 | 68788836909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8369-9)Marketed from Feb 1, 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)
- Simvastatin
- Generic name (nonproprietary)
- simvastatin
- Active ingredients
- Simvastatin — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078103
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-8369_7f31ae2f-4403-4305-bfe5-dcdcd83cdd1bSPL ID 7f31ae2f-4403-4305-bfe5-dcdcd83cdd1bSPL set ID e73ec981-e477-4412-befd-7b807aceb32eRxCUI 314231UNII AGG2FN16EV
- 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
N468788836901followed by a unit qualifier and the quantityPackage 68788-8369-01. 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)
Simvastatin tablets USP are 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): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering the…
Excerpt only. Read the full label for complete information.
About NDC 68788-8369
- What is NDC 68788-8369?
- 68788-8369 is the product NDC for Simvastatin, Simvastatin 10 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 4 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?
- 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 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 078103
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 10 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-478 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-479 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6236 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-387 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9717 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-798 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8406 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5788 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-809 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-966 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6306 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6307 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-579 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-580 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-464 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4331 |
| Simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-465 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-585 |
| Simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-168 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc | 42708-169 |
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