FDA.reportPublic FDA data

amiodarone hydrochloride

Product NDC
68382-297
11-digit product format
683820297
Labeler code
68382
Product ID
68382-297_b3f11ad6-9f3b-4054-9c51-3d2614c1002e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amiodarone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA079029
Marketing category
ANDA
Marketing start
2023-02-09
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 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 HYDROCHLORIDE100 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
68382-297-06amiodarone hydrochloride30 in 1 BOTTLETABLET3019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-297-06EA - Each68382-297f3509f73-48b0-4055-a58b-d4c40894d8da12023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMIODARONE HYDROCHLORIDEACTIVE INGREDIENT976728SY6ZAMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
AMIODARONEACTIVE MOIETYN3RQ532IUTAMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
POVIDONEINACTIVE INGREDIENTFZ989GH94EAMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-297AMIODARONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.]19Current NDC, 1 package rows20230317_b41cbcb5-9c5d-4e45-a4f2-952df5f22c00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSNb41cbcb5-9c5d-4e45-a4f2-952df5f22c0019
833528amiodarone HCl 200 MG Oral TabletPSNb41cbcb5-9c5d-4e45-a4f2-952df5f22c0019
834348amiodarone HCl 400 MG Oral TabletPSNb41cbcb5-9c5d-4e45-a4f2-952df5f22c0019
835956amiodarone hydrochloride 100 MG Oral TabletSCDb41cbcb5-9c5d-4e45-a4f2-952df5f22c0019
833528amiodarone hydrochloride 200 MG Oral TabletSCDb41cbcb5-9c5d-4e45-a4f2-952df5f22c0019
834348amiodarone hydrochloride 400 MG Oral TabletSCDb41cbcb5-9c5d-4e45-a4f2-952df5f22c0019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68382-297-066838202970630 TABLET in 1 BOTTLE (68382-297-06) 30 tablet2023-02-09NoNoCurrent