FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
0904-6993
11-digit product format
009046993
Labeler code
0904
Product ID
0904-6993_64f4746d-7518-4865-a7e4-8c3f17ace734
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075424
Marketing category
ANDA
Marketing start
2001-03-30
Marketing end
2027-01-31
Substance
AMIODARONE HYDROCHLORIDE
Active strength
200 mg/1
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amiodarone Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui833528

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
0904-6993-61Amiodarone Hydrochloride1 in 1 BLISTER PACKTABLET17
0904-6993-61Amiodarone Hydrochloride100 in 1 CARTONTABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6993-61EA - Each0904-6993611aadac-17b8-412d-8b79-7e3a6daa1e6312020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6993AMIODARONE HYDROCHLORIDE TABLET [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250524_352ed423-fc16-47bb-8e25-98e1c20f9991.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN7bdc2236-3a1a-4210-a9fb-38f860227aa79
833528amiodarone hydrochloride 200 MG Oral TabletSCD7bdc2236-3a1a-4210-a9fb-38f860227aa79
833528amiodarone HCl 200 MG Oral TabletPSN352ed423-fc16-47bb-8e25-98e1c20f99917
833528amiodarone hydrochloride 200 MG Oral TabletSCD352ed423-fc16-47bb-8e25-98e1c20f99917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6993-6100904699361100 BLISTER PACK in 1 CARTON (0904-6993-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2020-04-202027-01-31NoNoCurrent