Isoniazid

Product NDC
68788-9405
11-digit product format
687889405
Labeler code
68788
Product ID
68788-9405_558247ab-4b20-4398-9c35-51fa250acab0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA080937
Marketing category
ANDA
Marketing start
2014-11-03
Marketing end
2026-07-01
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Isoniazid

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISONIAZID300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV83O1VOZ8L
Rxcui197832

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-9405-1Isoniazid100 in 1 BOTTLETABLET10013
68788-9405-3Isoniazid30 in 1 BOTTLETABLET3013
68788-9405-6Isoniazid60 in 1 BOTTLETABLET6013
68788-9405-9Isoniazid90 in 1 BOTTLETABLET9013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]1
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9405ISONIAZID TABLET [PREFERRED PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 4 package rows20240530_e199dbfa-6d79-4c20-9984-9cd0c1907510.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNe199dbfa-6d79-4c20-9984-9cd0c190751013
197832isoniazid 300 MG Oral TabletSCDe199dbfa-6d79-4c20-9984-9cd0c190751013
197832INH 300 MG Oral TabletSYe199dbfa-6d79-4c20-9984-9cd0c190751013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9405-168788940501100 TABLET in 1 BOTTLE (68788-9405-1) 100 tablet2014-11-032026-07-01NoNoCurrent
68788-9405-36878894050330 TABLET in 1 BOTTLE (68788-9405-3) 30 tablet2014-11-032026-07-01NoNoCurrent
68788-9405-66878894050660 TABLET in 1 BOTTLE (68788-9405-6) 60 tablet2014-11-032026-07-01NoNoCurrent
68788-9405-96878894050990 TABLET in 1 BOTTLE (68788-9405-9) 90 tablet2014-11-032026-07-01NoNoCurrent