FDA.reportPublic FDA data

Amiodarone Hydrochloride

Product NDC
75907-006
11-digit product format
759070006
Labeler code
75907
Product ID
75907-006_e0bc8f4a-dc9b-7804-4479-ebe732449569
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Labratories Inc.
Application
ANDA075389
Marketing category
ANDA
Marketing start
2024-03-15
Marketing end
2027-06-30
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
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, 834348, 835956

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
75907-006-60Amiodarone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-006-60EA - Each75907-00658cadc70-81c7-45f5-9739-a9e6075b165c12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-006AMIODARONE HYDROCHLORIDE TABLET [DR. REDDY'S LABRATORIES INC.]1Current NDC, 1 package rows20240316_95cef33b-c0e6-b17c-7cbb-f5c066872705.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSN95cef33b-c0e6-b17c-7cbb-f5c0668727052
833528amiodarone HCl 200 MG Oral TabletPSN95cef33b-c0e6-b17c-7cbb-f5c0668727052
834348amiodarone HCl 400 MG Oral TabletPSN95cef33b-c0e6-b17c-7cbb-f5c0668727052
835956amiodarone hydrochloride 100 MG Oral TabletSCD95cef33b-c0e6-b17c-7cbb-f5c0668727052
833528amiodarone hydrochloride 200 MG Oral TabletSCD95cef33b-c0e6-b17c-7cbb-f5c0668727052
834348amiodarone hydrochloride 400 MG Oral TabletSCD95cef33b-c0e6-b17c-7cbb-f5c0668727052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75907-006-607590700066060 TABLET in 1 BOTTLE, PLASTIC (75907-006-60) 60 tablet2024-03-152027-06-30NoNoHistorical