amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-112
Product ID 68083-112_2c1bc6a8-20ff-483a-ae28-fb31fa5f684a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077161
Listing Expiration 2026-12-31
Marketing Start 2013-07-15

Pharmacologic Class

Classes
antiarrhythmic [epc] cytochrome p450 1a2 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083112
Hyphenated Format 68083-112

Supplemental Identifiers

RxCUI
834357
UPC
0368083112011
UNII
976728SY6Z

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 amiodarone hydrochloride (source: ndc)
Generic Name amiodarone hydrochloride (source: ndc)
Application Number ANDA077161 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 SYRINGE in 1 CARTON (68083-112-01) / 3 mL in 1 SYRINGE
source: ndc

Packages (1)

68083-112-01 10 SYRINGE in 1 CARTON (68083-112-01) / 3 mL in 1 SYRINGE

Ingredients (1)

amiodarone hydrochloride (50 mg/mL)

Linked Drug Pages (1)

Amiodarone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2c1bc6a8-20ff-483a-ae28-fb31fa5f684a", "openfda": {"upc": ["0368083112011"], "unii": ["976728SY6Z"], "rxcui": ["834357"], "spl_set_id": ["1f00c333-9667-4ebc-8849-009a3779c0c9"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 SYRINGE in 1 CARTON (68083-112-01)  / 3 mL in 1 SYRINGE", "package_ndc": "68083-112-01", "marketing_start_date": "20130715"}], "brand_name": "Amiodarone hydrochloride", "product_id": "68083-112_2c1bc6a8-20ff-483a-ae28-fb31fa5f684a", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antiarrhythmic [EPC]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "68083-112", "generic_name": "Amiodarone hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA077161", "marketing_category": "ANDA", "marketing_start_date": "20130715", "listing_expiration_date": "20261231"}