Prescription drug · NDA
Sular (Nisoldipine) NDC 70515-500
Nisoldipine 8.5 mg/1 · Tablet, Film coated, Extended release · Oral · Covis Pharma US, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70515-500-10 | 70515050010 | 1 BOTTLE in 1 CARTON (70515-500-10) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Feb 3, 2017 |
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)
- Sular
- Generic name (nonproprietary)
- nisoldipine
- Active ingredients
- Nisoldipine — 8.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Covis Pharma US, IncNDC labeler code 70515
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020356
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Decreased Blood Pressure (Physiologic effect)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 70515-500_daa4568e-f725-4df3-85eb-ff0ede789c78SPL ID daa4568e-f725-4df3-85eb-ff0ede789c78SPL set ID 589157fa-d129-4de3-be3d-e0e1c22c5873RxCUI 763519, 763521, 763589, 763591, 790489, 790840UNII 4I8HAB65SZUPC 0370515501102, 0370515503106
- Pharmacologic class
- Dihydropyridine Calcium Channel Blocker
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
N470515050010followed by a unit qualifier and the quantityPackage 70515-0500-10. 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)
INDICATIONS AND USAGE SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents.
Excerpt only. Read the full label for complete information.
About NDC 70515-500
- What is NDC 70515-500?
- 70515-500 is the product NDC for Sular (nisoldipine), Nisoldipine 8.5 mg/1 tablet, film coated, extended release, listed with the FDA by Covis Pharma US, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sular (Nisoldipine).
- What is the active ingredient?
- Nisoldipine.
- Who is the labeler?
- Covis Pharma US, Inc, NDC labeler code 70515. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sular?
- 2 other product NDCs are listed under this name. See all Sular NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sular products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sularnisoldipine | Nisoldipine 17 mg/1 | Tablet, Film coated, Extended releaseOral | Covis Pharma US, Inc | 70515-501 | 70515-0501-10 |
| Sularnisoldipine | Nisoldipine 34 mg/1 | Tablet, Film coated, Extended releaseOral | Covis Pharma US, Inc | 70515-503 | 70515-0503-10 |
Other NDCs under NDA 020356
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 |
|---|---|---|---|---|
| Nisoldipine | Nisoldipine 8.5 mg/1 | Tablet, Film coated, Extended releaseOral | Prasco Laboratories | 66993-472 |
| Nisoldipine | Nisoldipine 17 mg/1 | Tablet, Film coated, Extended releaseOral | Prasco Laboratories | 66993-473 |
| Nisoldipine | Nisoldipine 34 mg/1 | Tablet, Film coated, Extended releaseOral | Prasco Laboratories | 66993-475 |
| Sularnisoldipine | Nisoldipine 17 mg/1 | Tablet, Film coated, Extended releaseOral | Covis Pharma US, Inc | 70515-501 |
| Sularnisoldipine | Nisoldipine 34 mg/1 | Tablet, Film coated, Extended releaseOral | Covis Pharma US, Inc | 70515-503 |