FDA.reportPublic FDA data

Pacerone

Product NDC
0245-0144
11-digit product format
002450144
Labeler code
0245
Product ID
0245-0144_39e7666b-4916-2716-e063-6394a90a0589
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA075135
Marketing category
ANDA
Marketing start
2010-11-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pacerone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii976728SY6Z
Rxcui833528, 834346, 834348, 834350, 835956, 835958

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
0245-0144-01Pacerone100 in 1 CARTONTABLET10027
0245-0144-11Pacerone100 in 1 BOTTLETABLET10027
0245-0144-30Pacerone30 in 1 BOTTLETABLET3027
0245-0144-89Pacerone1 in 1 BLISTER PACKTABLET127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0144-01EA - Each0245-014452ac0ee2-5185-411c-baca-b8a4feed9aa612012-07-24
0245-0144-30EA - Each0245-01449f3788cb-5e7b-41a0-9e41-41aafe6fc93612012-07-24
0245-0144-89EA - Each0245-014438528244-7dc8-4200-b346-5bc4d32b0e0d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amiodarone HydrochlorideACTIVE INGREDIENT976728SY6ZPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
AmiodaroneACTIVE MOIETYN3RQ532IUTPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
magnesium stearateINACTIVE INGREDIENT70097M6I30PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
povidonesINACTIVE INGREDIENTFZ989GH94EPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
starch, cornINACTIVE INGREDIENTO8232NY3SJPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16
stearic acidINACTIVE INGREDIENT4ELV7Z65APPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0144PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, LLC]26Current NDC, Legacy NDC, 4 package rows20230602_4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835956amiodarone HCl 100 MG Oral TabletPSNdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835958Pacerone 100 MG Oral TabletPSNdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835958amiodarone hydrochloride 100 MG Oral Tablet [Pacerone]SBDdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835956amiodarone hydrochloride 100 MG Oral TabletSCDdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835958Pacerone 100 MG Oral TabletSYdcadce9c-d0a0-4235-8ff8-dd93c09e03b3101
835956amiodarone HCl 100 MG Oral TabletPSN4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
833528amiodarone HCl 200 MG Oral TabletPSN4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
834348amiodarone HCl 400 MG Oral TabletPSN4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
835958Pacerone 100 MG Oral TabletPSN4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
834346Pacerone 200 MG Oral TabletPSN4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
834350Pacerone 400 MG Oral TabletPSN4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
835958amiodarone hydrochloride 100 MG Oral Tablet [Pacerone]SBD4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
834346amiodarone hydrochloride 200 MG Oral Tablet [Pacerone]SBD4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
834350amiodarone hydrochloride 400 MG Oral Tablet [Pacerone]SBD4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
835956amiodarone hydrochloride 100 MG Oral TabletSCD4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
833528amiodarone hydrochloride 200 MG Oral TabletSCD4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
834348amiodarone hydrochloride 400 MG Oral TabletSCD4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
835958Pacerone 100 MG Oral TabletSY4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
834346Pacerone 200 MG Oral TabletSY4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727
834350Pacerone 400 MG Oral TabletSY4c4ec9b0-13a5-49a8-b57b-b3f64e4316a727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0245-0144-0100245014401100 BLISTER PACK in 1 CARTON (0245-0144-01) / 1 TABLET in 1 BLISTER PACK (0245-0144-89) 100 blister pack2011-01-190000-00-00NoNoCurrent
0245-0144-1100245014411100 TABLET in 1 BOTTLE (0245-0144-11) 100 tablet2011-01-190000-00-00NoNoCurrent
0245-0144-300024501443030 TABLET in 1 BOTTLE (0245-0144-30) 30 tablet2011-01-190000-00-00NoNoCurrent
0245-0144-89002450144891 in 1 BLISTER PACKHistorical