Prescription drug · NDA
Cardene IV (Nicardipine hydrochloride) NDC 43066-021
Nicardipine hydrochloride .1 mg/mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43066-021-10 | 43066002110 | 10 BAG in 1 CARTON (43066-021-10) / 200 mL in 1 BAGMarketed from Aug 22, 2020 |
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)
- Cardene IV
- Generic name (nonproprietary)
- nicardipine hydrochloride
- Active ingredients
- Nicardipine hydrochloride — .1 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 43066
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019734
- 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 43066-021_bf4088a4-3cf9-4963-bfdd-79a641a552d7SPL ID bf4088a4-3cf9-4963-bfdd-79a641a552d7SPL set ID 5499cfac-9147-4d5d-a8cb-f8d64f1481afRxCUI 858599, 858601, 858603, 858605UNII 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
N443066002110followed by a unit qualifier and the quantityPackage 43066-0021-10. 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)
• CARDENE I.V. is a calcium channel blocker indicated for the short-term treatment of hypertension in adults when oral therapy is not feasible. ( 1.1 ) 1.1 Hypertension CARDENE I.V. (nicardipine hydrochloride) is indicated in adults for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits [see Dosage and Administration (2.1) ].
Excerpt only. Read the full label for complete information.
About NDC 43066-021
- What is NDC 43066-021?
- 43066-021 is the product NDC for Cardene IV (nicardipine hydrochloride), Nicardipine hydrochloride .1 mg/mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cardene IV (Nicardipine hydrochloride).
- What is the active ingredient?
- Nicardipine hydrochloride.
- Who is the labeler?
- Baxter Healthcare Corporation, NDC labeler code 43066. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cardene IV?
- 6 other product NDCs are listed under this name. See all Cardene IV NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cardene IV products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .1 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-009 | 43066-0009-10 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-016 | 43066-0016-10 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-024 | 43066-0024-10 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .1 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-026 | 43066-0026-10 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-028 | 43066-0028-10 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride 2.5 mg/10mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-029 | 43066-0029-10 |
Other NDCs under NDA 019734
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 |
|---|---|---|---|---|
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .1 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-009 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-016 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-024 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .1 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-026 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride .2 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-028 |
| Cardene IVnicardipine hydrochloride | Nicardipine hydrochloride 2.5 mg/10mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 43066-029 |