Prescription drug · ANDA
nicardipine hydrochloride NDC 71288-204
Nicardipine hydrochloride 2.5 mg/mL · Injection, Solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-204-11 | 7128802041171288020411 | 10 VIAL, SINGLE-DOSE in 1 CARTON (71288-204-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-204-10)Marketed from Aug 20, 2025 |
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 — 2.5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216819
- 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 71288-204_e47a5b80-6fcf-4cbf-8ca2-965a60f7d926SPL ID e47a5b80-6fcf-4cbf-8ca2-965a60f7d926SPL set ID 372a4381-7302-4df7-81bb-a9521907f867RxCUI 858607UNII 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
N471288020411followed by a unit qualifier and the quantityPackage 71288-0204-11. 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 Injection 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 Nicardipine Hydrochloride Injection 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 71288-204
- What is NDC 71288-204?
- 71288-204 is the product NDC for nicardipine hydrochloride, Nicardipine hydrochloride 2.5 mg/mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- nicardipine hydrochloride.
- What is the active ingredient?
- Nicardipine hydrochloride.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for nicardipine hydrochloride?
- 43 other product NDCs are listed under this name. See all nicardipine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other nicardipine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nicardipine Hydrochloride | Nicardipine hydrochloride .1 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-296 | 65219-0296-20 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride .2 mg/mL | InjectionIntravenous | Fresenius Kabi USA, LLC | 65219-298 | 65219-0298-20 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride 20 mg/1 | CapsuleOral | Amerisyn LLC | 87564-027 | 87564-0027-90 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride 30 mg/1 | CapsuleOral | Amerisyn LLC | 87564-028 | 87564-0028-90 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride .1 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-197 | 65145-0197-10 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride .2 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-198 | 65145-0198-10 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride .1 mg/mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-875 | 70069-0875-10 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride .2 mg/mL | InjectionIntravenous | Somerset Therapeutics, LLC | 70069-876 | 70069-0876-10 |
| Nicardipine hydrochloride | Nicardipine hydrochloride 2.5 mg/mL | InjectionIntravenous | Lifestar Pharma LLC | 70756-686 | 70756-0686-10 |
| Nicardipine Hydrochloride | Nicardipine hydrochloride 20 mg/1 | CapsuleOral | Amici Pharma Inc | 69292-620 | 69292-0620-90 |