FDA.reportPublic FDA data

Isosorbide Dinitrate

Product NDC
51407-147
11-digit product format
514070147
Labeler code
51407
Product ID
51407-147_47e94658-ec5c-4e31-e063-6294a90a80ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isosorbide Dinitrate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA088088
Marketing category
ANDA
Marketing start
1987-10-29
Substance
ISOSORBIDE DINITRATE
Active strength
5 mg/1
Pharmacologic classes
Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isosorbide Dinitrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOSORBIDE DINITRATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiIA7306519N
Rxcui206842, 314055, 381056

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e9ed2ee5-d109-4795-bffe-c3b047717749Product name220250107
1ee44c84-1ad7-16b4-788d-a549f91b0f44Product name420230316
0dcc68a5-df0d-b1a6-ba71-3da99d94ffe9Product name120140508
b0c258c1-3fb1-4785-4031-5c4417fb7ecdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-147-01Isosorbide Dinitrate100 in 1 BOTTLE, PLASTICTABLET1007
51407-147-10Isosorbide Dinitrate1000 in 1 BOTTLE, PLASTICTABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-147-01EA - Each51407-147196e7016-25f2-4f73-8724-091e05614c2812019-02-13
51407-147-10EA - Each51407-147aa6c224f-b52d-4c9b-b1ff-dec53b60c63c12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-147ISOSORBIDE DINITRATE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]6Current NDC, Legacy NDC, 2 package rows20240302_7f860fbd-f130-4652-e053-2991aa0a402e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
381056isosorbide dinitrate 10 MG Oral TabletPSN7f860fbd-f130-4652-e053-2991aa0a402e7
206842isosorbide dinitrate 20 MG Oral TabletPSN7f860fbd-f130-4652-e053-2991aa0a402e7
314055isosorbide dinitrate 5 MG Oral TabletPSN7f860fbd-f130-4652-e053-2991aa0a402e7
381056isosorbide dinitrate 10 MG Oral TabletSCD7f860fbd-f130-4652-e053-2991aa0a402e7
206842isosorbide dinitrate 20 MG Oral TabletSCD7f860fbd-f130-4652-e053-2991aa0a402e7
314055isosorbide dinitrate 5 MG Oral TabletSCD7f860fbd-f130-4652-e053-2991aa0a402e7
381056ISDN 10 MG Oral TabletSY7f860fbd-f130-4652-e053-2991aa0a402e7
206842ISDN 20 MG Oral TabletSY7f860fbd-f130-4652-e053-2991aa0a402e7
314055ISDN 5 MG Oral TabletSY7f860fbd-f130-4652-e053-2991aa0a402e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-147-0151407014701100 TABLET in 1 BOTTLE, PLASTIC (51407-147-01) 100 tablet2018-12-170000-00-00NoNoCurrent
51407-147-10514070147101000 TABLET in 1 BOTTLE, PLASTIC (51407-147-10) 1000 tablet2018-12-170000-00-00NoNoCurrent