Isoniazid

Product NDC
51079-083
11-digit product format
510790083
Labeler code
51079
Product ID
51079-083_2c63f06e-644c-83aa-e063-6394a90a879a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA080937
Marketing category
ANDA
Marketing start
1994-06-09
Marketing end
2026-11-30
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
51079-083-01Isoniazid1 in 1 BLISTER PACKTABLET111
51079-083-20Isoniazid100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-083-01EA - Each51079-08340b5d3c1-c3a1-4d07-95b2-8d7163f97cc312012-07-24
51079-083-20EA - Each51079-08375a5777b-396b-45f1-9e8b-02b973f2079512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISONIAZIDACTIVE INGREDIENTV83O1VOZ8LISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
ISONIAZIDACTIVE MOIETYV83O1VOZ8LISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-083ISONIAZID TABLET [MYLAN INSTITUTIONAL INC.]11Current NDC, Legacy NDC, 2 package rows20250125_60a6b514-fa7f-4bc7-85b0-e5a14fa56b59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSN60a6b514-fa7f-4bc7-85b0-e5a14fa56b5911
197832isoniazid 300 MG Oral TabletSCD60a6b514-fa7f-4bc7-85b0-e5a14fa56b5911
197832INH 300 MG Oral TabletSY60a6b514-fa7f-4bc7-85b0-e5a14fa56b5911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-083-01510790083011 in 1 BLISTER PACKHistorical
51079-083-2051079008320100 BLISTER PACK in 1 CARTON (51079-083-20) / 1 TABLET in 1 BLISTER PACK (51079-083-01) 100 blister pack1994-06-092026-11-30NoNoCurrent