Prescription drug · NDA
Zocor (Simvastatin) NDC 78206-182
Simvastatin 40 mg/1 · Tablet, Film coated · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-182-01 | 7820601820178206018201 | 30 TABLET, FILM COATED in 1 BOTTLE (78206-182-01)Marketed from Jun 1, 2021 | |
| 78206-182-02 | 7820601820278206018202 | 90 TABLET, FILM COATED in 1 BOTTLE (78206-182-02)Marketed from Jun 1, 2021 |
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)
- Zocor
- Generic name (nonproprietary)
- simvastatin
- Active ingredients
- Simvastatin — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019766
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 78206-182_11256523-425c-48e8-afe1-e3a4e28c892eSPL ID 11256523-425c-48e8-afe1-e3a4e28c892eSPL set ID 8f55d5de-5a4f-4a39-8c84-c53976dd6af9RxCUI 104490, 104491, 152923, 198211, 312961, 314231UNII AGG2FN16EVUPC 0378206182012, 0378206180018, 0378206181015
- 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
N478206018201followed by a unit qualifier and the quantityPackage 78206-0182-01. 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)
ZOCOR ® 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 in a…
Excerpt only. Read the full label for complete information.
About NDC 78206-182
- What is NDC 78206-182?
- 78206-182 is the product NDC for Zocor (simvastatin), Simvastatin 40 mg/1 tablet, film coated, listed with the FDA by Organon LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zocor (Simvastatin).
- What is the active ingredient?
- Simvastatin.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zocor?
- 2 other product NDCs are listed under this name. See all Zocor NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zocor products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zocorsimvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-180 | 78206-0180-0178206-0180-02 |
| Zocorsimvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-181 | 78206-0181-0178206-0181-02 |
Other NDCs under NDA 019766
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 |
|---|---|---|---|---|
| Zocorsimvastatin | Simvastatin 10 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-180 |
| Zocorsimvastatin | Simvastatin 20 mg/1 | Tablet, Film coatedOral | Organon LLC | 78206-181 |