amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-616
Product ID 63323-616_262974e7-d551-4123-adfa-2ee1c4fa6195
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075761
Listing Expiration 2026-12-31
Marketing Start 2003-01-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323616
Hyphenated Format 63323-616

Supplemental Identifiers

RxCUI
1663224 1663244
UPC
0363323616021 0363323616014
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 ANDA075761 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-616-01)
  • 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09) / 9 mL in 1 VIAL, SINGLE-DOSE (63323-616-02)
source: ndc

Packages (2)

63323-616-03 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03) / 3 mL in 1 VIAL, SINGLE-DOSE (63323-616-01) 63323-616-09 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09) / 9 mL in 1 VIAL, SINGLE-DOSE (63323-616-02)

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": "262974e7-d551-4123-adfa-2ee1c4fa6195", "openfda": {"upc": ["0363323616021", "0363323616014"], "unii": ["976728SY6Z"], "rxcui": ["1663224", "1663244"], "spl_set_id": ["d8d04647-8e25-4127-8ecf-360ce1991c2f"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-03)  / 3 mL in 1 VIAL, SINGLE-DOSE (63323-616-01)", "package_ndc": "63323-616-03", "marketing_start_date": "20030128"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 TRAY (63323-616-09)  / 9 mL in 1 VIAL, SINGLE-DOSE (63323-616-02)", "package_ndc": "63323-616-09", "marketing_start_date": "20030128"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "63323-616_262974e7-d551-4123-adfa-2ee1c4fa6195", "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 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "63323-616", "generic_name": "AMIODARONE HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA075761", "marketing_category": "ANDA", "marketing_start_date": "20030128", "listing_expiration_date": "20261231"}