nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: qilu pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler qilu pharmaceutical co., ltd.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine hydrochloride 2.5 mg/mL

Manufacturer
Qilu Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 67184-0611
Product ID 67184-0611_ea3b2399-f7da-417a-aa1d-b4525235b820
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219608
Listing Expiration 2027-12-31
Marketing Start 2025-10-28

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 671840611
Hyphenated Format 67184-0611

Supplemental Identifiers

RxCUI
858607
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 ANDA219608 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (67184-0611-2) / 10 mL in 1 VIAL (67184-0611-1)
source: ndc

Packages (1)

67184-0611-2 10 VIAL in 1 CARTON (67184-0611-2) / 10 mL in 1 VIAL (67184-0611-1)

Ingredients (1)

nicardipine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

Nicardipine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ea3b2399-f7da-417a-aa1d-b4525235b820", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858607"], "spl_set_id": ["7433b5cd-9c3a-428a-bcaf-00f02cd52633"], "manufacturer_name": ["Qilu Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (67184-0611-2)  / 10 mL in 1 VIAL (67184-0611-1)", "package_ndc": "67184-0611-2", "marketing_start_date": "20260101"}], "brand_name": "Nicardipine Hydrochloride", "product_id": "67184-0611_ea3b2399-f7da-417a-aa1d-b4525235b820", "dosage_form": "INJECTION, SOLUTION", "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": "67184-0611", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "Qilu Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nicardipine Hydrochloride", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "ANDA219608", "marketing_category": "ANDA", "marketing_start_date": "20251028", "listing_expiration_date": "20271231"}