NICARDIPINE HYDROCHLORIDE
- Product NDC
- 65219-818
- 11-digit product format
- 652190818
- Labeler code
- 65219
- Product ID
- 65219-818_457af9c7-009c-4323-88fb-eb3b3a8e4b62
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nicardipine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA217548
- Marketing category
- ANDA
- Marketing start
- 2024-09-11
- Substance
- NICARDIPINE HYDROCHLORIDE
- Active strength
- 25 mg/10mL
- 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 | 25 mg/10mL |
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 |
|---|
| 65219-818-03 | NICARDIPINE HYDROCHLORIDE | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | | 3 |
| 65219-818-10 | NICARDIPINE HYDROCHLORIDE | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | | 3 |
| 65219-818-10 | NICARDIPINE HYDROCHLORIDE | 1 in 1 CARTON | INJECTION | 1 | | 3 |
| 65219-818-13 | NICARDIPINE HYDROCHLORIDE | 10 in 1 CARTON | INJECTION | 10 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65219-818 | NICARDIPINE HYDROCHLORIDE INJECTION [FRESENIUS KABI USA, LLC] | 1 | Current NDC, 4 package rows | 20240915_cdafe6cc-b03e-4e72-9d0a-6baa977149d6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 65219-818-03 | 65219081803 | 10 mL in 1 VIAL, GLASS | 10 ml | | | | Historical |
| 65219-818-10 | 65219081810 | 1 VIAL, GLASS in 1 CARTON (65219-818-10) / 10 mL in 1 VIAL, GLASS | | 2024-09-11 | No | No | Historical |
| 65219-818-13 | 65219081813 | 10 VIAL, GLASS in 1 CARTON (65219-818-13) / 10 mL in 1 VIAL, GLASS (65219-818-03) | | 2025-11-17 | No | No | Historical |