FDA.reportPublic FDA data

isosorbide dinitrate and hydralazine hydrochloride

Product NDC
52536-006
11-digit product format
525360006
Labeler code
52536
Product ID
52536-006_13386839-9eb4-4956-a788-d94a7b63cb77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydralazine hydrochloride and isosorbide dinitrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wilshire Pharmaceuticals
Application
NDA020727
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2022-04-15
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
52536-006-09isosorbide dinitrate and hydralazine hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52536-006-09EA - Each52536-006f28f3fe0-7d9f-41f5-bb50-e2156e0e296812022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52536-006ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE (HYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATE) TABLET, FILM COATED [WILSHIRE PHARMACEUTICALS]2Current NDC, Legacy NDC, 1 package rows20220416_620a0680-aad0-4923-84be-7393c0cbdcbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905377isosorbide dinitrate 20 MG / hydrALAZINE HCl 37.5 MG Oral TabletPSN2a6fe05a-fcd4-42d1-bf5d-1d39ac2733632
905377isosorbide dinitrate 20 MG / hydrALAZINE HCl 37.5 MG Oral TabletPSN620a0680-aad0-4923-84be-7393c0cbdcbd2
905377hydralazine hydrochloride 37.5 MG / isosorbide dinitrate 20 MG Oral TabletSCD2a6fe05a-fcd4-42d1-bf5d-1d39ac2733632
905377hydralazine hydrochloride 37.5 MG / isosorbide dinitrate 20 MG Oral TabletSCD620a0680-aad0-4923-84be-7393c0cbdcbd2
905377Hydralazine Hydrochloride 37.5 MG / ISDN 20 MG Oral TabletSY2a6fe05a-fcd4-42d1-bf5d-1d39ac2733632
905377Hydralazine Hydrochloride 37.5 MG / ISDN 20 MG Oral TabletSY620a0680-aad0-4923-84be-7393c0cbdcbd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52536-006-095253600060990 TABLET, FILM COATED in 1 BOTTLE (52536-006-09) 2022-04-150000-00-00NoNoCurrent