Isoniazid

Product NDC
0555-0066
11-digit product format
005550066
Labeler code
0555
Product ID
0555-0066_ead93989-8a7e-4483-917e-388152515e1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA080936
Marketing category
ANDA
Marketing start
1972-09-01
Marketing end
2026-12-31
Substance
ISONIAZID
Active strength
100 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
ISONIAZID100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV83O1VOZ8L
Rxcui197832, 311166

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
0555-0066-02Isoniazid100 in 1 BOTTLETABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0066-02EA - Each0555-00663033a0ca-4de0-44ad-9256-4e53e229594112012-07-24
0555-0066-05EA - Each0555-00660b11c98b-d676-4bad-b7a9-e4c2abd04daa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [BARR LABORATORIES INC.]4
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [BARR LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISONIAZID TABLET [BARR LABORATORIES INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKISONIAZID TABLET [BARR LABORATORIES INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISONIAZID TABLET [BARR LABORATORIES INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJISONIAZID TABLET [BARR LABORATORIES INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UISONIAZID TABLET [BARR LABORATORIES INC.]4
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]1
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UISONIAZID TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0066ISONIAZID TABLET [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 1 package rows20241211_9499f1cf-2f46-4047-8b71-90aee7dee854.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311166isoniazid 100 MG Oral TabletPSN8a309582-1bb7-4b21-af43-c38710ac83d521
311166isoniazid 100 MG Oral TabletSCD8a309582-1bb7-4b21-af43-c38710ac83d521
311166INH 100 MG Oral TabletSY8a309582-1bb7-4b21-af43-c38710ac83d521
311166isoniazid 100 MG Oral TabletPSN9499f1cf-2f46-4047-8b71-90aee7dee85414
197832isoniazid 300 MG Oral TabletPSN9499f1cf-2f46-4047-8b71-90aee7dee85414
311166isoniazid 100 MG Oral TabletSCD9499f1cf-2f46-4047-8b71-90aee7dee85414
197832isoniazid 300 MG Oral TabletSCD9499f1cf-2f46-4047-8b71-90aee7dee85414
311166INH 100 MG Oral TabletSY9499f1cf-2f46-4047-8b71-90aee7dee85414
197832INH 300 MG Oral TabletSY9499f1cf-2f46-4047-8b71-90aee7dee85414
311166isoniazid 100 MG Oral TabletPSN2b87aa05-8028-1b46-e054-00144ff8d46c2
197832isoniazid 300 MG Oral TabletPSN2b87aa05-8028-1b46-e054-00144ff8d46c2
311166isoniazid 100 MG Oral TabletSCD2b87aa05-8028-1b46-e054-00144ff8d46c2
197832isoniazid 300 MG Oral TabletSCD2b87aa05-8028-1b46-e054-00144ff8d46c2
311166INH 100 MG Oral TabletSY2b87aa05-8028-1b46-e054-00144ff8d46c2
197832INH 300 MG Oral TabletSY2b87aa05-8028-1b46-e054-00144ff8d46c2
311166isoniazid 100 MG Oral TabletPSN63dd70bb-e79b-4fa4-93f1-3144403548131
197832isoniazid 300 MG Oral TabletPSN63dd70bb-e79b-4fa4-93f1-3144403548131
311166isoniazid 100 MG Oral TabletSCD63dd70bb-e79b-4fa4-93f1-3144403548131
197832isoniazid 300 MG Oral TabletSCD63dd70bb-e79b-4fa4-93f1-3144403548131
311166INH 100 MG Oral TabletSY63dd70bb-e79b-4fa4-93f1-3144403548131
197832INH 300 MG Oral TabletSY63dd70bb-e79b-4fa4-93f1-3144403548131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0066-0200555006602100 TABLET in 1 BOTTLE (0555-0066-02) 100 tablet1972-09-012026-12-31NoNoCurrent