Nicardipine Hydrochloride
- Product NDC
- 67184-0611
- 11-digit product format
- 671840611
- Labeler code
- 67184
- Product ID
- 67184-0611_ea3b2399-f7da-417a-aa1d-b4525235b820
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nicardipine Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA219608
- Marketing category
- ANDA
- Marketing start
- 2025-10-28
- Substance
- NICARDIPINE HYDROCHLORIDE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicardipine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICARDIPINE HYDROCHLORIDE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K5BC5011K3 |
| Rxcui | 858607 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67184-0611-1 | Nicardipine Hydrochloride | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 9 |
| 67184-0611-2 | Nicardipine Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 9 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67184-0611-1 | 67184061101 | 10 mL in 1 VIAL | 10 ml | | | | Historical |
| 67184-0611-2 | 67184061102 | 10 VIAL in 1 CARTON (67184-0611-2) / 10 mL in 1 VIAL (67184-0611-1) | 10 vial | 2026-01-01 | No | No | Historical |