Nicardipine Hydrochloride
- Product NDC
- 65145-197
- 11-digit product format
- 651450197
- Labeler code
- 65145
- Product ID
- 65145-197_9383f1dc-0310-4c87-a8f0-48c09a85d89b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nicardipine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Caplin Steriles Limited
- Application
- ANDA220243
- Marketing category
- ANDA
- Marketing start
- 2025-11-04
- Substance
- NICARDIPINE HYDROCHLORIDE
- Active strength
- .1 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicardipine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICARDIPINE HYDROCHLORIDE | .1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K5BC5011K3 |
| Rxcui | 858599, 858603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65145-197-01 | Nicardipine Hydrochloride | 200 mL in 1 BAG | INJECTION | 200 | | 1 |
| 65145-197-01 | Nicardipine Hydrochloride | 1 in 1 POUCH | INJECTION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65145-197-01 | 65145019701 | 1 BAG in 1 POUCH (65145-197-01) / 200 mL in 1 BAG | 1 bag | 2025-11-04 | No | No | Current |