Nicardipine Hydrochloride
- Product NDC
- 68462-120
- 11-digit product format
- 684620120
- Labeler code
- 68462
- Product ID
- 68462-120_eb131915-222b-49d9-8e66-cd0f0afd066c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nicardipine Hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA216357
- Marketing category
- ANDA
- Marketing start
- 2022-12-16
- 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
- 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 | 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 |
|---|
| 68462-120-05 | Nicardipine Hydrochloride | 500 in 1 BOTTLE | CAPSULE | 500 | | 3 |
| 68462-120-90 | Nicardipine Hydrochloride | 90 in 1 BOTTLE | CAPSULE | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-120 | NICARDIPINE HYDROCHLORIDE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] | 2 | Current NDC, Legacy NDC, 2 package rows | 20240104_3955d43d-a87f-4d2c-b90e-3ecf0d6aa148.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 |
|---|
| 68462-120-05 | 68462012005 | 500 CAPSULE in 1 BOTTLE (68462-120-05) | 500 capsule | 2022-12-16 | 0000-00-00 | No | No | Current |
| 68462-120-90 | 68462012090 | 90 CAPSULE in 1 BOTTLE (68462-120-90) | 90 capsule | 2022-12-16 | 0000-00-00 | No | No | Current |