FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
70518-1231
11-digit product format
705181231
Labeler code
70518
Product ID
70518-1231_48c17e3b-f248-1cef-e063-6294a90a467b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA077234
Marketing category
ANDA
Marketing start
2018-05-30
Substance
AMIODARONE HYDROCHLORIDE
Active strength
50 mg/mL
Pharmacologic 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]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amiodarone Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui1663224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
555d5389-223f-1ce8-3064-82307acfdb0dProduct name420250325
b88d5283-0ee6-f0b3-21f1-5522444ef3dfProduct name320210204
555d5389-223f-1ce8-3064-82307acfdb0dProduct name320171213
1f5577c0-bdff-03f7-f803-d1d3f05329c2Product name120140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1231-0Amiodarone Hydrochloride3 mL in 1 VIALINJECTION, SOLUTION311
70518-1231-1Amiodarone Hydrochloride25 in 1 BOXINJECTION, SOLUTION2511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1231AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 2 package rows20250509_e9151c1b-b70c-477b-868a-fffdc5c51830.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1663224amiodarone HCl 150 MG in 3 ML InjectionPSNe9151c1b-b70c-477b-868a-fffdc5c5183011
16632243 ML amiodarone hydrochloride 50 MG/ML InjectionSCDe9151c1b-b70c-477b-868a-fffdc5c5183011
1663224amiodarone HCl 150 MG per 3 ML InjectionSYe9151c1b-b70c-477b-868a-fffdc5c5183011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1231-0705181231003 mL in 1 VIAL3 mlHistorical
70518-1231-17051812310125 VIAL in 1 BOX (70518-1231-1) / 3 mL in 1 VIAL (70518-1231-0) 25 vial2018-05-300000-00-00NoNoCurrent