FDA.reportPublic FDA data

Isoniazid

Product NDC
51655-391
11-digit product format
516550391
Labeler code
51655
Product ID
51655-391_691af6ba-bce1-4977-b03b-3180ca53d8e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA080937
Marketing category
ANDA
Marketing start
2014-07-14
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0c158ae5-31fa-5bc4-3cf2-0aa120f1417dProduct name120140508
26abd97e-907b-0cb8-84ee-99fb15297adaProduct name120140508
7cf7f62d-3767-728f-c117-96e96c1ed8bfProduct name120140508
9e3dea0d-7fd5-1a7e-e095-3b9e72f40538Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-391-242026-01-10C16284748780-19d75b9d0-1b4c-f424-e053-dadaa90a57ceIsoniazid 300 MG
51655-391-242020-01-31C16284748780-19d75b9d0-1b4c-f424-e053-dadaa90a57ceIsoniazid 300 MG

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [NORTHWIND PHARMACEUTICALS, LLC]1
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [NORTHWIND PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-391ISONIAZID TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Legacy NDC20140723_9c34d487-693b-43e3-803e-45d87425e3d6.zip