amiodarone hydrochloride

Generic: amiodarone hydrochloride

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

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 200 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3439
Product ID 70518-3439_3a995757-782f-ce96-e063-6294a90a6441
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078578
Listing Expiration 2026-12-31
Marketing Start 2022-06-14

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 705183439
Hyphenated Format 70518-3439

Supplemental Identifiers

RxCUI
833528
UNII
976728SY6Z

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 ANDA078578 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3439-0)
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3439-1)
source: ndc

Packages (2)

70518-3439-0 30 TABLET in 1 BLISTER PACK (70518-3439-0) 70518-3439-1 90 TABLET in 1 BOTTLE, PLASTIC (70518-3439-1)

Ingredients (1)

amiodarone hydrochloride (200 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": "3a995757-782f-ce96-e063-6294a90a6441", "openfda": {"unii": ["976728SY6Z"], "rxcui": ["833528"], "spl_set_id": ["337c5695-e3f8-41c6-a088-a492d5c60215"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3439-0)", "package_ndc": "70518-3439-0", "marketing_start_date": "20220614"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3439-1)", "package_ndc": "70518-3439-1", "marketing_start_date": "20221218"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "70518-3439_3a995757-782f-ce96-e063-6294a90a6441", "dosage_form": "TABLET", "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": "70518-3439", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "200 mg/1"}], "application_number": "ANDA078578", "marketing_category": "ANDA", "marketing_start_date": "20220614", "listing_expiration_date": "20261231"}