Prescription drug · ANDA
Nicardipine Hydrochloride NDC 69097-007
Nicardipine hydrochloride .1 mg/mL · Injection · Intravenous · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-007-22 | 69097000722 | 10 BAG in 1 CARTON (69097-007-22) / 200 mL in 1 BAG (69097-007-45)Marketed from Oct 2, 2024 |
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 — .1 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215592
- 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 69097-007_d477e259-4e07-433c-b230-d3dd63331866SPL ID d477e259-4e07-433c-b230-d3dd63331866SPL set ID 570af1f8-6718-4b40-ae89-0f738d330ebdRxCUI 858599, 858603UNII CZ5312222S, K5BC5011K3
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N469097000722followed by a unit qualifier and the quantityPackage 69097-0007-22. 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)
Nicardipine hydrochloride in 0.9% sodium chloride injection is a calcium channel blocker indicated for the short-term treatment of hypertension when oral therapy is not feasible. 1.1 Hypertension Nicardipine hydrochloride in 0.9% sodium chloride injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration ( 2.6 )] .
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215592
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 .2 mg/mL | InjectionIntravenous | Cipla USA Inc. | 69097-008 |