FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
60687-437
11-digit product format
606870437
Labeler code
60687
Product ID
60687-437_437dba0c-f63e-5d43-e063-6394a90a9602
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA204742
Marketing category
ANDA
Marketing start
2019-09-30
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
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 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
60687-437-01Amiodarone Hydrochloride100 in 1 BOX, UNIT-DOSETABLET1007
60687-437-11Amiodarone Hydrochloride1 in 1 BLISTER PACKTABLET17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-437-01EA - Each60687-43788e62f6b-ac8c-4a64-9f41-88949bc902ab12019-09-05
60687-437-11EA - Each60687-4371c5c59e0-9f4b-494a-b630-15413479d85312019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-437AMIODARONE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20240426_d912a75a-ddac-4e7b-b5c4-321d4252ec05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b8
833528amiodarone hydrochloride 200 MG Oral TabletSCD0caedb97-56fd-4ec0-bfb2-c7683b8f5f1b8
833528amiodarone HCl 200 MG Oral TabletPSNd912a75a-ddac-4e7b-b5c4-321d4252ec057
833528amiodarone hydrochloride 200 MG Oral TabletSCDd912a75a-ddac-4e7b-b5c4-321d4252ec057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-437-0160687043701100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-437-01) / 1 TABLET in 1 BLISTER PACK (60687-437-11) 100 blister pack2019-09-300000-00-00NoNoCurrent
60687-437-11606870437111 in 1 BLISTER PACKHistorical