Isoniazid

Product NDC
52959-145
11-digit product format
529590145
Labeler code
52959
Product ID
52959-145_aa8209f7-358e-4f9c-aaaf-1bde912f0a68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-145-00Isoniazid100 in 1 BOTTLETABLET1001
52959-145-02Isoniazid270 in 1 BOTTLETABLET2701
52959-145-30Isoniazid30 in 1 BOTTLETABLET301
52959-145-50Isoniazid50 in 1 BOTTLETABLET501
52959-145-60Isoniazid60 in 1 BOTTLETABLET601
52959-145-81Isoniazid180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-145-00EA - Each52959-145056c9e2e-db91-4a6c-922b-ce640b276f1a12012-07-24
52959-145-30EA - Each52959-14595ef8986-ab18-4955-a4d5-ac0cb666ba0712012-07-24
52959-145-50EA - Each52959-145061f28a0-14a1-4c55-b034-693844c8b02912012-07-24
52959-145-60EA - Each52959-145b5a3f903-ae30-47a3-948a-0da3b69e2d2912012-07-24
52959-145-81EA - Each52959-14523e357e1-4873-419a-8290-1b7c0f08ac3112012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-145ISONIAZID TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 6 package rows20111208_e43d77c2-f7e8-4d84-9425-37adb38410f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNe43d77c2-f7e8-4d84-9425-37adb38410f01
197832isoniazid 300 MG Oral TabletSCDe43d77c2-f7e8-4d84-9425-37adb38410f01
197832INH 300 MG Oral TabletSYe43d77c2-f7e8-4d84-9425-37adb38410f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-145-0052959014500100 in 1 BOTTLEHistorical
52959-145-0252959014502270 in 1 BOTTLEHistorical
52959-145-305295901453030 in 1 BOTTLEHistorical
52959-145-505295901455050 in 1 BOTTLEHistorical
52959-145-605295901456060 in 1 BOTTLEHistorical
52959-145-8152959014581180 in 1 BOTTLEHistorical