FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
50268-097
11-digit product format
502680097
Labeler code
50268
Product ID
50268-097_47e23673-1380-50b5-e063-6394a90a9314
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA075389
Marketing category
ANDA
Marketing start
2019-09-11
Substance
AMIODARONE HYDROCHLORIDE
Active strength
100 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
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 HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui835956

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
50268-097-11Amiodarone Hydrochloride1 in 1 BLISTER PACKTABLET15
50268-097-15Amiodarone Hydrochloride50 in 1 BOXTABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-097-11EA - Each50268-0975f19c02b-6200-4889-9c5f-9dc1f3e3691a12019-10-07
50268-097-15EA - Each50268-097d303708e-bf94-48be-b168-2379688bb7a912019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-097AMIODARONE HYDROCHLORIDE TABLET [AVPAK]4Current NDC, Legacy NDC, 2 package rows20241010_924c9359-ebc4-62a7-e053-2a95a90a4327.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSN924c9359-ebc4-62a7-e053-2a95a90a43275
835956amiodarone hydrochloride 100 MG Oral TabletSCD924c9359-ebc4-62a7-e053-2a95a90a43275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-097-11502680097111 in 1 BLISTER PACKHistorical
50268-097-155026800971550 BLISTER PACK in 1 BOX (50268-097-15) / 1 TABLET in 1 BLISTER PACK (50268-097-11) 50 blister pack2019-09-110000-00-00NoNoCurrent