Nicardipine Hydrochloride
- Product NDC
- 42806-501
- 11-digit product format
- 428060501
- Labeler code
- 42806
- Product ID
- 42806-501_cdaf4385-811f-4e33-9990-b4e2586b81b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nicardipine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA074928
- Marketing category
- ANDA
- Marketing start
- 2010-05-05
- 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 |
|---|
| 42806-501-01 | Nicardipine Hydrochloride | 100 in 1 BOTTLE | CAPSULE | 100 | | 10 |
| 42806-501-05 | Nicardipine Hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | | 10 |
| 42806-501-09 | Nicardipine Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 10 |
| 42806-501-10 | Nicardipine Hydrochloride | 1000 in 1 BOTTLE | CAPSULE | 1000 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NICARDIPINE HYDROCHLORIDE | ACTIVE INGREDIENT | K5BC5011K3 | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| NICARDIPINE | ACTIVE MOIETY | CZ5312222S | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-501 | NICARDIPINE HYDROCHLORIDE CAPSULE [EPIC PHARMA, LLC] | 10 | Current NDC, Legacy NDC, 4 package rows | 20231228_b8f147b8-955f-4733-9178-2cfa0beb60d6.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 |
|---|
| 42806-501-01 | 42806050101 | 100 CAPSULE in 1 BOTTLE (42806-501-01) | 100 capsule | 2010-05-05 | 0000-00-00 | No | No | Current |
| 42806-501-05 | 42806050105 | 500 CAPSULE in 1 BOTTLE (42806-501-05) | 500 capsule | 2010-05-05 | 0000-00-00 | No | No | Current |
| 42806-501-09 | 42806050109 | 90 CAPSULE in 1 BOTTLE (42806-501-09) | 90 capsule | 2010-05-05 | 0000-00-00 | No | No | Current |
| 42806-501-10 | 42806050110 | 1000 CAPSULE in 1 BOTTLE (42806-501-10) | 1000 capsule | 2010-05-05 | 0000-00-00 | No | No | Current |