amiodarone hydrochloride

Generic: amiodarone hydrochloride

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

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 100 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-297
Product ID 68382-297_b3f11ad6-9f3b-4054-9c51-3d2614c1002e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079029
Listing Expiration 2026-12-31
Marketing Start 2023-02-09

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 68382297
Hyphenated Format 68382-297

Supplemental Identifiers

RxCUI
833528 834348 835956
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 ANDA079029 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68382-297-06)
source: ndc

Packages (1)

68382-297-06 30 TABLET in 1 BOTTLE (68382-297-06)

Ingredients (1)

amiodarone hydrochloride (100 mg/1)

Linked Drug Pages (1)

amiodarone hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b3f11ad6-9f3b-4054-9c51-3d2614c1002e", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528", "834348", "835956"], "spl_set_id": ["b41cbcb5-9c5d-4e45-a4f2-952df5f22c00"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-297-06)", "package_ndc": "68382-297-06", "marketing_start_date": "20230209"}], "brand_name": "amiodarone hydrochloride", "product_id": "68382-297_b3f11ad6-9f3b-4054-9c51-3d2614c1002e", "dosage_form": "TABLET", "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": "68382-297", "generic_name": "amiodarone hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "amiodarone hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA079029", "marketing_category": "ANDA", "marketing_start_date": "20230209", "listing_expiration_date": "20261231"}