nicardipine hydrochloride

Generic: nicardipine hydrochloride

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nicardipine hydrochloride
Generic Name nicardipine hydrochloride
Labeler cipla usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

nicardipine .2 mg/mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-008
Product ID 69097-008_d477e259-4e07-433c-b230-d3dd63331866
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215592
Listing Expiration 2026-12-31
Marketing Start 2024-10-02

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa] cytochrome p450 3a4 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] cytochrome p450 2c19 inhibitors [moa]
Chemical Structure
dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097008
Hyphenated Format 69097-008

Supplemental Identifiers

RxCUI
858599 858603
UNII
CZ5312222S K5BC5011K3
NUI
N0000000069 N0000175421 M0006414 N0000182141 N0000182137 N0000187062 N0000182140

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 ANDA215592 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .2 mg/mL
source: ndc
Packaging
  • 10 BAG in 1 CARTON (69097-008-22) / 200 mL in 1 BAG (69097-008-45)
source: ndc

Packages (1)

69097-008-22 10 BAG in 1 CARTON (69097-008-22) / 200 mL in 1 BAG (69097-008-45)

Ingredients (1)

nicardipine (.2 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": "d477e259-4e07-433c-b230-d3dd63331866", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414", "N0000182141", "N0000182137", "N0000187062", "N0000182140"], "unii": ["CZ5312222S", "K5BC5011K3"], "rxcui": ["858599", "858603"], "spl_set_id": ["570af1f8-6718-4b40-ae89-0f738d330ebd"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BAG in 1 CARTON (69097-008-22)  / 200 mL in 1 BAG (69097-008-45)", "package_ndc": "69097-008-22", "marketing_start_date": "20241002"}], "brand_name": "NICARDIPINE HYDROCHLORIDE", "product_id": "69097-008_d477e259-4e07-433c-b230-d3dd63331866", "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": "69097-008", "generic_name": "nicardipine hydrochloride", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NICARDIPINE HYDROCHLORIDE", "active_ingredients": [{"name": "NICARDIPINE", "strength": ".2 mg/mL"}], "application_number": "ANDA215592", "marketing_category": "ANDA", "marketing_start_date": "20241002", "listing_expiration_date": "20261231"}