amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: dr. reddy's labratories inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler dr. reddy's labratories inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

amiodarone hydrochloride 400 mg/1

Manufacturer
Dr. Reddy's Labratories Inc.

Identifiers & Regulatory

Product NDC 75907-007
Product ID 75907-007_a6748f21-3b0f-53cc-5047-51f305834108
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075389
Listing Expiration 2026-12-31
Marketing Start 2024-03-15

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 75907007
Hyphenated Format 75907-007

Supplemental Identifiers

RxCUI
833528 834348 835956
UPC
0375907005305
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 ANDA075389 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (75907-007-30)
source: ndc

Packages (1)

75907-007-30 30 TABLET in 1 BOTTLE, PLASTIC (75907-007-30)

Ingredients (1)

amiodarone hydrochloride (400 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": "a6748f21-3b0f-53cc-5047-51f305834108", "openfda": {"upc": ["0375907005305"], "unii": ["976728SY6Z"], "rxcui": ["833528", "834348", "835956"], "spl_set_id": ["95cef33b-c0e6-b17c-7cbb-f5c066872705"], "manufacturer_name": ["Dr. Reddy's Labratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (75907-007-30)", "package_ndc": "75907-007-30", "marketing_start_date": "20240315"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "75907-007_a6748f21-3b0f-53cc-5047-51f305834108", "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": "75907-007", "generic_name": "Amiodarone Hydrochloride", "labeler_name": "Dr. Reddy's Labratories Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA075389", "marketing_category": "ANDA", "marketing_start_date": "20240315", "listing_expiration_date": "20261231"}