nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nicardipine hydrochloride 20 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-120
Product ID 68462-120_eb131915-222b-49d9-8e66-cd0f0afd066c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216357
Listing Expiration 2027-12-31
Marketing Start 2022-12-16

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462120
Hyphenated Format 68462-120

Supplemental Identifiers

RxCUI
858613 858616
UPC
0368462121900 0368462120903
UNII
K5BC5011K3

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nicardipine hydrochloride (source: ndc)
Generic Name nicardipine hydrochloride (source: ndc)
Application Number ANDA216357 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 500 CAPSULE in 1 BOTTLE (68462-120-05)
  • 90 CAPSULE in 1 BOTTLE (68462-120-90)
source: ndc

Packages (2)

68462-120-05 500 CAPSULE in 1 BOTTLE (68462-120-05) 68462-120-90 90 CAPSULE in 1 BOTTLE (68462-120-90)

Ingredients (1)

nicardipine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Nicardipine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eb131915-222b-49d9-8e66-cd0f0afd066c", "openfda": {"upc": ["0368462121900", "0368462120903"], "unii": ["K5BC5011K3"], "rxcui": ["858613", "858616"], "spl_set_id": ["3955d43d-a87f-4d2c-b90e-3ecf0d6aa148"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68462-120-05)", "package_ndc": "68462-120-05", "marketing_start_date": "20221216"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (68462-120-90)", "package_ndc": "68462-120-90", "marketing_start_date": "20221216"}], "brand_name": "Nicardipine Hydrochloride", "product_id": "68462-120_eb131915-222b-49d9-8e66-cd0f0afd066c", "dosage_form": "CAPSULE", "pharm_class": ["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]"], "product_ndc": "68462-120", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine Hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA216357", "marketing_category": "ANDA", "marketing_start_date": "20221216", "listing_expiration_date": "20271231"}