Prescription drug · ANDA
simvastatin NDC 43063-733
Simvastatin 80 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-733-30 | 4306307333043063073330 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-733-30)Marketed from Dec 28, 2016 |
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 — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.NDC labeler code 43063
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078155
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 43063-733_51a5e93d-b458-c3b7-e063-6294a90a7165SPL ID 51a5e93d-b458-c3b7-e063-6294a90a7165SPL set ID c6b610ab-7367-4e61-9b4a-7ebbd1cf3d36RxCUI 200345UNII AGG2FN16EVUPC 0343063733301
- 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
N443063073330followed by a unit qualifier and the quantityPackage 43063-0733-30. 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)
1. INDICATIONS AND USAGE Simvastatin tablet 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): 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…
Excerpt only. Read the full label for complete information.
About NDC 43063-733
- What is NDC 43063-733?
- 43063-733 is the product NDC for simvastatin, Simvastatin 80 mg/1 tablet, film coated, listed with the FDA by PD-Rx Pharmaceuticals, Inc.. It has 1 package NDC, 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?
- PD-Rx Pharmaceuticals, Inc., NDC labeler code 43063. 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?
- 156 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 40 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0628 | 67046-0628-03 |
| Simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0626 | 67046-0626-03 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0542 | 67046-0542-03 |
| 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 20 mg/1 | Tablet, Film coatedOral | XLCare Pharmaceuticals Inc. | 72865-307 | 72865-0307-0172865-0307-1072865-0307-30+2 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 40 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-376 | 69367-0376-0969367-0376-10 |
| Simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-374 | 69367-0374-0969367-0374-10 |
Other NDCs under ANDA 078155
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 | Accord Healthcare, Inc. | 16729-004 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-005 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-006 |
| simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-007 |
| simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Accord Healthcare, Inc. | 16729-156 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-148 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-726 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-727 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4897 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-598 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-643 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-075 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-191 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-449 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3385 |
| simvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3392 |
| simvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3393 |
| simvastatin | Simvastatin 80 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3408 |
| simvastatin | Simvastatin 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-7421 |
| simvastatin | Simvastatin 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-1646 |
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