nicardipine hydrochloride

Generic: nicardipine hydrochloride

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

Drug Facts

Product Profile

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

nicardipine hydrochloride 25 mg/10mL

Manufacturer
Chengdu Shuode Pharmaceutical Co., Ltd

Identifiers & Regulatory

Product NDC 82432-103
Product ID 82432-103_434901d7-2140-d6d8-e063-6394a90a07c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217548
Listing Expiration 2026-12-31
Marketing Start 2024-09-11

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 82432103
Hyphenated Format 82432-103

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 ANDA217548 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 25 mg/10mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (82432-103-01) / 10 mL in 1 VIAL, GLASS
  • 10 VIAL, GLASS in 1 CARTON (82432-103-02) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (2)

82432-103-01 1 VIAL, GLASS in 1 CARTON (82432-103-01) / 10 mL in 1 VIAL, GLASS 82432-103-02 10 VIAL, GLASS in 1 CARTON (82432-103-02) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

nicardipine hydrochloride (25 mg/10mL)

Linked Drug Pages (1)

NICARDIPINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "434901d7-2140-d6d8-e063-6394a90a07c4", "openfda": {"unii": ["K5BC5011K3"], "rxcui": ["858607"], "spl_set_id": ["433dbca3-0a86-44c2-835d-1051c1c93878"], "manufacturer_name": ["Chengdu Shuode Pharmaceutical Co., Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (82432-103-01)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "82432-103-01", "marketing_start_date": "20240911"}, {"sample": false, "description": "10 VIAL, GLASS in 1 CARTON (82432-103-02)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "82432-103-02", "marketing_start_date": "20251117"}], "brand_name": "NICARDIPINE HYDROCHLORIDE", "product_id": "82432-103_434901d7-2140-d6d8-e063-6394a90a07c4", "dosage_form": "INJECTION", "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": "82432-103", "generic_name": "Nicardipine Hydrochloride", "labeler_name": "Chengdu Shuode Pharmaceutical Co., Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NICARDIPINE HYDROCHLORIDE", "active_ingredients": [{"name": "NICARDIPINE HYDROCHLORIDE", "strength": "25 mg/10mL"}], "application_number": "ANDA217548", "marketing_category": "ANDA", "marketing_start_date": "20240911", "listing_expiration_date": "20261231"}