Nicardipine Hydrochloride
- Product NDC
- 0517-0735
- 11-digit product format
- 005170735
- Labeler code
- 0517
- Product ID
- 0517-0735_92ab3adc-2097-490a-a0b3-fa3fac098a2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nicardipine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- American Regent, Inc.
- Application
- ANDA090534
- Marketing category
- ANDA
- Marketing start
- 2020-05-08
- 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
- 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 | 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 |
|---|
| 0517-0735-01 | Nicardipine Hydrochloride | 10 mL in 1 VIAL | INJECTION, SOLUTION | 10 | | 9 |
| 0517-0735-10 | Nicardipine Hydrochloride | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0517-0735 | NICARDIPINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.] | 9 | Current NDC, Legacy NDC, 2 package rows | 20201209_76fcb7e0-9034-4fcd-be14-ce7e9ccaee2a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0517-0735-01 | 00517073501 | 10 mL in 1 VIAL | 10 ml | | | | | Historical |
| 0517-0735-10 | 00517073510 | 10 VIAL in 1 CARTON (0517-0735-10) / 10 mL in 1 VIAL (0517-0735-01) | 10 vial | 2020-05-08 | 0000-00-00 | No | No | Current |