Prescription drug · ANDA
Nicardipine Hydrochloride NDC 35573-458
Nicardipine hydrochloride 30 mg/1 · Capsule · Oral · Burel Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 35573-458-85 | 35573045885 | 90 CAPSULE in 1 BOTTLE (35573-458-85)Marketed from Jan 8, 2023 |
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)
- Nicardipine Hydrochloride
- Generic name (nonproprietary)
- nicardipine hydrochloride
- Active ingredients
- Nicardipine hydrochloride — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Burel Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215377
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 35573-458_f47b85b1-a7d3-437b-a3db-a81e1f1716c4SPL ID f47b85b1-a7d3-437b-a3db-a81e1f1716c4SPL set ID cb902af0-b5ad-4680-b2f2-007ef2196efeRxCUI 858613, 858616UNII K5BC5011K3UPC 0335573457853, 0335573458850
- 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
N435573045885followed by a unit qualifier and the quantityPackage 35573-0458-85. 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 I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are indicated for the treatment of hypertension. Nicardipine hydrochloride capsules may be used alone or in combination with other antihypertensive drugs. In administering nicardipine hydrochloride it is important to be aware of the relatively large peak to trough differences in blood pressure effect (See DOSAGE AND ADMINISTRATION ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215377
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 |
|---|---|---|---|---|
| Nicardipine Hydrochloride | Nicardipine hydrochloride 20 mg/1 | CapsuleOral | Amici Pharma Inc | 69292-620 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride 30 mg/1 | CapsuleOral | Amici Pharma Inc | 69292-621 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride 20 mg/1 | CapsuleOral | Burel Pharmaceuticals, LLC | 35573-457 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride 30 mg/1 | CapsuleOral | Amerisyn LLC | 87564-028 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride 20 mg/1 | CapsuleOral | Amerisyn LLC | 87564-027 |