FDA.reportPublic FDA data

Pacerone

Product NDC
71610-787
11-digit product format
716100787
Labeler code
71610
Product ID
71610-787_f373ed89-c786-4f7c-a55e-2d1dc62971b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amiodarone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, 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

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
71610-787-30Pacerone30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-787-30EA - Each71610-7875b4a1d8d-73b6-43ce-9d3c-a82dfb9a5ade12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-787PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 1 package rows20240206_02f4a736-63ed-4ad4-a1f1-b21a71e928bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833528amiodarone HCl 200 MG Oral TabletPSN02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
834346Pacerone 200 MG Oral TabletPSN02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
834346amiodarone hydrochloride 200 MG Oral Tablet [Pacerone]SBD02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
833528amiodarone hydrochloride 200 MG Oral TabletSCD02f4a736-63ed-4ad4-a1f1-b21a71e928bd1
834346Pacerone 200 MG Oral TabletSY02f4a736-63ed-4ad4-a1f1-b21a71e928bd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-787-307161007873030 TABLET in 1 BOTTLE (71610-787-30) 30 tablet2024-01-25NoNoHistorical