FDA.reportPublic FDA data

isosorbide dinitrate and hydralazine hydrochloride

Product NDC
72319-012
11-digit product format
723190012
Labeler code
72319
Product ID
72319-012_1898d58a-a951-f2a3-e063-6394a90a5e9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isosorbide dinitrate and hydralazine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
i3 Pharmaceuticals, LLC
Application
ANDA215988
Marketing category
ANDA
Marketing start
2024-02-07
Substance
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Active strength
37.5; 20 mg/1; mg/1
Pharmacologic classes
Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
isosorbide dinitrate and hydralazine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDRALAZINE HYDROCHLORIDE37.5 mg/1
ISOSORBIDE DINITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFD171B778Y, IA7306519N
Rxcui905377

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3137695-e199-b3b3-2950-87a8ac429689Product name520260316
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
1ee44c84-1ad7-16b4-788d-a549f91b0f44Product name420230316
0284f4a6-db58-dacf-18fe-da73f4aeea88Product name420180827
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
0dcc68a5-df0d-b1a6-ba71-3da99d94ffe9Product name120140508
b0c258c1-3fb1-4785-4031-5c4417fb7ecdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72319-012-03isosorbide dinitrate and hydralazine hydrochloride90 in 1 BOTTLETABLET, FILM COATED907
72319-012-18isosorbide dinitrate and hydralazine hydrochloride180 in 1 BOTTLETABLET, FILM COATED1807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72319-012-03EA - Each72319-0124bb71685-66c2-4d8f-a6c3-7c7eb818934512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72319-012ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [I3 PHARMACEUTICALS, LLC]7Current NDC, 2 package rows20240529_cacf1a7c-0388-09ee-e053-2995a90a10cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905377isosorbide dinitrate 20 MG / hydrALAZINE HCl 37.5 MG Oral TabletPSNcacf1a7c-0388-09ee-e053-2995a90a10cf7
905377hydralazine hydrochloride 37.5 MG / isosorbide dinitrate 20 MG Oral TabletSCDcacf1a7c-0388-09ee-e053-2995a90a10cf7
905377Hydralazine Hydrochloride 37.5 MG / ISDN 20 MG Oral TabletSYcacf1a7c-0388-09ee-e053-2995a90a10cf7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72319-012-037231900120390 TABLET, FILM COATED in 1 BOTTLE (72319-012-03) 2024-02-07NoNoHistorical
72319-012-1872319001218180 TABLET, FILM COATED in 1 BOTTLE (72319-012-18) 2024-02-07NoNoHistorical