NICARDIPINE HYDROCHLORIDE
- Product NDC
- 35573-457
- 11-digit product format
- 355730457
- Labeler code
- 35573
- Product ID
- 35573-457_f47b85b1-a7d3-437b-a3db-a81e1f1716c4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- nicardipine hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, LLC
- Application
- ANDA215377
- Marketing category
- ANDA
- Marketing start
- 2023-01-08
- Substance
- NICARDIPINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- 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 | 20 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K5BC5011K3 |
| Rxcui | 858613, 858616 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35573-457-85 | NICARDIPINE HYDROCHLORIDE | 90 in 1 BOTTLE | CAPSULE | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35573-457 | NICARDIPINE HYDROCHLORIDE CAPSULE [BUREL PHARMACEUTICALS, LLC] | 2 | Current NDC, 1 package rows | 20231109_cb902af0-b5ad-4680-b2f2-007ef2196efe.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 |
|---|
| 35573-457-85 | 35573045785 | 90 CAPSULE in 1 BOTTLE (35573-457-85) | 90 capsule | 2023-01-08 | No | No | Current |