Isoniazid

Product NDC
61748-013
11-digit product format
617480013
Labeler code
61748
Product ID
61748-013_1247f0c8-25be-49b0-96e1-22b1cf50dc00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
VersaPharm Incorporated
Application
ANDA087425
Marketing category
ANDA
Marketing start
1997-09-01
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
61748-013-012020-01-31C16284748780-19d75b9d1-009c-f424-e053-dadaa90a57ceISONIAZID TABLETS, USP
61748-013-102020-01-31C16284748780-19d75b9d1-009c-f424-e053-dadaa90a57ceISONIAZID TABLETS, USP
61748-013-302020-01-31C16284748780-19d75b9d1-009c-f424-e053-dadaa90a57ceISONIAZID TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61748-013-01Isoniazid100 in 1 BOTTLETABLET1001
61748-013-10Isoniazid1000 in 1 BOTTLETABLET10001
61748-013-30Isoniazid30 in 1 BOTTLETABLET301

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61748-013ISONIAZID TABLET [VERSAPHARM INCORPORATED]1Legacy NDC, 3 package rows20120803_1247f0c8-25be-49b0-96e1-22b1cf50dc00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311166isoniazid 100 MG Oral TabletPSN1247f0c8-25be-49b0-96e1-22b1cf50dc001
197832isoniazid 300 MG Oral TabletPSN1169212a-8192-5337-e054-00144ff88e881
197832isoniazid 300 MG Oral TabletPSN116d86ea-6a9d-00f3-e054-00144ff88e881
197832isoniazid 300 MG Oral TabletPSN1247f0c8-25be-49b0-96e1-22b1cf50dc001
311166isoniazid 100 MG Oral TabletSCD1247f0c8-25be-49b0-96e1-22b1cf50dc001
197832isoniazid 300 MG Oral TabletSCD1169212a-8192-5337-e054-00144ff88e881
197832isoniazid 300 MG Oral TabletSCD116d86ea-6a9d-00f3-e054-00144ff88e881
197832isoniazid 300 MG Oral TabletSCD1247f0c8-25be-49b0-96e1-22b1cf50dc001
311166INH 100 MG Oral TabletSY1247f0c8-25be-49b0-96e1-22b1cf50dc001
197832INH 300 MG Oral TabletSY1169212a-8192-5337-e054-00144ff88e881
197832INH 300 MG Oral TabletSY116d86ea-6a9d-00f3-e054-00144ff88e881
197832INH 300 MG Oral TabletSY1247f0c8-25be-49b0-96e1-22b1cf50dc001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61748-013-0161748001301100 in 1 BOTTLEHistorical
61748-013-10617480013101000 in 1 BOTTLEHistorical
61748-013-306174800133030 in 1 BOTTLEHistorical