FDA.reportPublic FDA data

Pacerone

Product NDC
0245-0147
11-digit product format
002450147
Labeler code
0245
Product ID
0245-0147_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
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
Pacerone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIODARONE HYDROCHLORIDE200 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
0245-0147-01Pacerone100 in 1 CARTONTABLET10027
0245-0147-15Pacerone500 in 1 BOTTLETABLET50027
0245-0147-60Pacerone60 in 1 BOTTLETABLET6027
0245-0147-89Pacerone1 in 1 BLISTER PACKTABLET127
0245-0147-90Pacerone90 in 1 BOTTLETABLET9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-0147-01EA - Each0245-01476d9373ff-0b0d-496a-816b-07d9f9f9caee12012-07-24
0245-0147-15EA - Each0245-0147defae207-ff10-402a-b817-97b58ebe28a912012-07-24
0245-0147-60EA - Each0245-01479bdfd677-0cae-4ea4-a63f-1256bd37530b12012-07-24
0245-0147-89EA - Each0245-0147af3c2db5-10ca-4b77-9df9-d56d62d806f412013-02-13
0245-0147-90EA - Each0245-01473c3046b9-5f69-4ca8-ba1b-c0acec0916e212012-07-24

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
Amiodarone HydrochlorideACTIVE INGREDIENT976728SY6ZPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
AmiodaroneACTIVE MOIETYN3RQ532IUTPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
magnesium stearateINACTIVE INGREDIENT70097M6I30PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
povidonesINACTIVE INGREDIENTFZ989GH94EPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
starch, cornINACTIVE INGREDIENTO8232NY3SJPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3
AMIODARONE HYDROCHLORIDEACTIVE INGREDIENT976728SY6ZPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
AMIODARONEACTIVE MOIETYN3RQ532IUTPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPACERONE (AMIODARONE HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0245-0147PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, LLC]26Current NDC, Legacy NDC, 5 package rows20230602_4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
833528amiodarone HCl 200 MG Oral TabletPSN2eceb4d5-0c47-49c3-8263-46f689388efe4
834346Pacerone 200 MG Oral TabletPSN2eceb4d5-0c47-49c3-8263-46f689388efe4
834346amiodarone hydrochloride 200 MG Oral Tablet [Pacerone]SBD2eceb4d5-0c47-49c3-8263-46f689388efe4
833528amiodarone hydrochloride 200 MG Oral TabletSCD2eceb4d5-0c47-49c3-8263-46f689388efe4
834346Pacerone 200 MG Oral TabletSY2eceb4d5-0c47-49c3-8263-46f689388efe4
833528amiodarone HCl 200 MG Oral TabletPSNbac761ca-9467-49d9-b6fc-b57cd27ee5f71
833528amiodarone HCl 200 MG Oral TabletPSN02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
834346Pacerone 200 MG Oral TabletPSN02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
834346Pacerone 200 MG Oral TabletPSNbac761ca-9467-49d9-b6fc-b57cd27ee5f71
834346amiodarone hydrochloride 200 MG Oral Tablet [Pacerone]SBDbac761ca-9467-49d9-b6fc-b57cd27ee5f71
834346amiodarone hydrochloride 200 MG Oral Tablet [Pacerone]SBD02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
833528amiodarone hydrochloride 200 MG Oral TabletSCD02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
833528amiodarone hydrochloride 200 MG Oral TabletSCDbac761ca-9467-49d9-b6fc-b57cd27ee5f71
834346Pacerone 200 MG Oral TabletSY02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
834346Pacerone 200 MG Oral TabletSYbac761ca-9467-49d9-b6fc-b57cd27ee5f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0245-0147-0100245014701100 BLISTER PACK in 1 CARTON (0245-0147-01) / 1 TABLET in 1 BLISTER PACK (0245-0147-89) 100 blister pack2011-01-190000-00-00NoNoCurrent
0245-0147-1500245014715500 TABLET in 1 BOTTLE (0245-0147-15) 500 tablet2011-01-190000-00-00NoNoCurrent
0245-0147-600024501476060 TABLET in 1 BOTTLE (0245-0147-60) 60 tablet2011-01-190000-00-00NoNoCurrent
0245-0147-89002450147891 in 1 BLISTER PACKHistorical
0245-0147-900024501479090 TABLET in 1 BOTTLE (0245-0147-90) 90 tablet2011-01-190000-00-00NoNoCurrent