FDA.reportPublic FDA data

Isoniazid

Product NDC
0440-7655
11-digit product format
004407655
Labeler code
0440
Product ID
0440-7655_295934bd-dc1c-463b-8daa-f653d6e95174
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA087425
Marketing category
ANDA
Marketing start
1981-07-14
Marketing end
0000-00-00
Substance
ISONIAZID
Active strength
300 mg/1
Pharmacologic classes
Antimycobacterial [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
0440-7655-302020-01-31C16284748780-19d75b9d1-0d14-f424-e053-dadaa90a57ceISONIAZID TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7655-30Isoniazid30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]1
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7655ISONIAZID TABLET [LIBERTY PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20131204_c50ce37b-c963-4eb0-bc22-8189efca7533.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNc50ce37b-c963-4eb0-bc22-8189efca75331
197832isoniazid 300 MG Oral TabletSCDc50ce37b-c963-4eb0-bc22-8189efca75331
197832INH 300 MG Oral TabletSYc50ce37b-c963-4eb0-bc22-8189efca75331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7655-300044076553030 in 1 BOTTLE, PLASTICHistorical