FDA.reportPublic FDA data

Amiodarone hydrochloride

Product NDC
68083-112
11-digit product format
680830112
Labeler code
68083
Product ID
68083-112_2c1bc6a8-20ff-483a-ae28-fb31fa5f684a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA077161
Marketing category
ANDA
Marketing start
2013-07-15
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 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amiodarone hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui834357

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a0ee8fe5-e56a-6ca2-24dc-111ec6d188e4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-112-01Amiodarone hydrochloride3 mL in 1 SYRINGEINJECTION, SOLUTION35
68083-112-01Amiodarone hydrochloride10 in 1 CARTONINJECTION, SOLUTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-112AMIODARONE HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]5Current NDC, Legacy NDC, 2 package rows20210827_1f00c333-9667-4ebc-8849-009a3779c0c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
834357amiodarone HCl 150 MG in 3 ML Prefilled SyringePSN1f00c333-9667-4ebc-8849-009a3779c0c95
8343573 ML amiodarone hydrochloride 50 MG/ML Prefilled SyringeSCD1f00c333-9667-4ebc-8849-009a3779c0c95
834357amiodarone hydrochloride 150 MG per 3 ML Prefilled SyringeSY1f00c333-9667-4ebc-8849-009a3779c0c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68083-112-016808301120110 SYRINGE in 1 CARTON (68083-112-01) / 3 mL in 1 SYRINGE10 syringe2013-07-150000-00-00NoNoCurrent