amiodarone hydrochloride

Generic: amiodarone hydrochloride

Labeler: zhejiang poly pharm. co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name amiodarone hydrochloride
Generic Name amiodarone hydrochloride
Labeler zhejiang poly pharm. co., ltd.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

amiodarone hydrochloride 50 mg/mL

Manufacturer
Zhejiang Poly Pharm. Co., Ltd.

Identifiers & Regulatory

Product NDC 72673-073
Product ID 72673-073_487d000e-9dec-3e6f-e063-6294a90ae8b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218253
Listing Expiration 2027-12-31
Marketing Start 2023-02-06

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 72673073
Hyphenated Format 72673-073

Supplemental Identifiers

RxCUI
1663224 1663244 1663248
UPC
0372673073019 0372673072104
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 ANDA218253 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 18 mL in 1 VIAL, GLASS (72673-073-01)
source: ndc

Packages (1)

72673-073-01 18 mL in 1 VIAL, GLASS (72673-073-01)

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": "487d000e-9dec-3e6f-e063-6294a90ae8b0", "openfda": {"upc": ["0372673073019", "0372673072104"], "unii": ["976728SY6Z"], "rxcui": ["1663224", "1663244", "1663248"], "spl_set_id": ["0a28ae25-7cc4-4ac0-a2ba-7820fb93e25c"], "manufacturer_name": ["Zhejiang Poly Pharm. Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "18 mL in 1 VIAL, GLASS (72673-073-01)", "package_ndc": "72673-073-01", "marketing_start_date": "20230206"}], "brand_name": "Amiodarone Hydrochloride", "product_id": "72673-073_487d000e-9dec-3e6f-e063-6294a90ae8b0", "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": "72673-073", "generic_name": "amiodarone hydrochloride", "labeler_name": "Zhejiang Poly Pharm. Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Amiodarone Hydrochloride", "active_ingredients": [{"name": "AMIODARONE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA218253", "marketing_category": "ANDA", "marketing_start_date": "20230206", "listing_expiration_date": "20271231"}