FDA.reportPublic FDA data

Isosorbide dinitrate and hydralazine hydrochloride

Product NDC
50742-246
11-digit product format
507420246
Labeler code
50742
Product ID
50742-246_3ba1968f-1fbf-4136-8bcd-c2af2fc93a83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide dinitrate and hydralazine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA215586
Marketing category
ANDA
Marketing start
2022-04-12
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
50742-246-18Isosorbide dinitrate and hydralazine hydrochloride180 in 1 BOTTLETABLET1806
50742-246-90Isosorbide dinitrate and hydralazine hydrochloride90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-246-18EA - Each50742-2463fe11cd6-0a9a-4c8c-835c-75ba4978344412022-05-04
50742-246-90EA - Each50742-246c48d9a9c-1eca-41f1-a2bf-8ea875d8920c12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-246ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE TABLET [INGENUS PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20221129_8f54d5a3-169f-48dd-9250-2c176d2bd9ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905377isosorbide dinitrate 20 MG / hydrALAZINE HCl 37.5 MG Oral TabletPSN8f54d5a3-169f-48dd-9250-2c176d2bd9ad6
905377hydralazine hydrochloride 37.5 MG / isosorbide dinitrate 20 MG Oral TabletSCD8f54d5a3-169f-48dd-9250-2c176d2bd9ad6
905377Hydralazine Hydrochloride 37.5 MG / ISDN 20 MG Oral TabletSY8f54d5a3-169f-48dd-9250-2c176d2bd9ad6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50742-246-1850742024618180 TABLET in 1 BOTTLE (50742-246-18) 180 tablet2022-04-120000-00-00NoNoCurrent
50742-246-905074202469090 TABLET in 1 BOTTLE (50742-246-90) 90 tablet2022-04-120000-00-00NoNoCurrent