FDA.reportPublic FDA data

Pacerone

Product NDC
0245-1645
11-digit product format
002451645
Labeler code
0245
Product ID
0245-1645_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
2020-07-02
Substance
AMIODARONE HYDROCHLORIDE
Active strength
400 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 HYDROCHLORIDE400 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
0245-1645-01Pacerone100 in 1 CARTONTABLET10027
0245-1645-30Pacerone30 in 1 BOTTLETABLET3027
0245-1645-89Pacerone1 in 1 BLISTER PACKTABLET127

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0245-1645-89EA - Each0245-1645e9264d7b-ff52-4d8b-b8d2-02d60df7ff2512025-05-14

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
0245-1645PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [UPSHER-SMITH LABORATORIES, LLC]26Current NDC, Legacy NDC, 3 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0245-1645-0100245164501100 BLISTER PACK in 1 CARTON (0245-1645-01) / 1 TABLET in 1 BLISTER PACK (0245-1645-89) 100 blister pack2020-10-010000-00-00NoNoCurrent
0245-1645-300024516453030 TABLET in 1 BOTTLE (0245-1645-30) 30 tablet2020-10-010000-00-00NoNoCurrent
0245-1645-89002451645891 in 1 BLISTER PACKHistorical