FDA.reportPublic FDA data

Isoniazid

Product NDC
50090-0370
11-digit product format
500900370
Labeler code
50090
Product ID
50090-0370_5f976d7d-c1ee-4a7a-b0f8-4e84092419a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA080937
Marketing category
ANDA
Marketing start
1972-09-01
Marketing end
2027-06-30
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0370-02023-02-07C16284748780-1f386c649-dd83-0266-e053-dadaa90a7c1aIsoniazid Tablets, USP
50090-0370-12023-02-07C16284748780-1f386c649-dd83-0266-e053-dadaa90a7c1aIsoniazid Tablets, USP
50090-0370-32023-02-07C16284748780-1f386c649-dd83-0266-e053-dadaa90a7c1aIsoniazid Tablets, USP
50090-0370-02023-01-30C16284748780-1f386c649-dd83-0266-e053-dadaa90a7c1aIsoniazid Tablets, USP
50090-0370-12023-01-30C16284748780-1f386c649-dd83-0266-e053-dadaa90a7c1aIsoniazid Tablets, USP
50090-0370-32023-01-30C16284748780-1f386c649-dd83-0266-e053-dadaa90a7c1aIsoniazid Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0370-0Isoniazid50 in 1 BOTTLETABLET5016
50090-0370-1Isoniazid100 in 1 BOTTLETABLET10016
50090-0370-3Isoniazid30 in 1 BOTTLETABLET3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0370-3EA - Each50090-0370245d7c0d-a419-4cb9-8ff0-1b10d886237a12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0370ISONIAZID TABLET [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 3 package rows20250508_d5039796-6ba0-4fa8-84f7-e47c63d45163.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNd5039796-6ba0-4fa8-84f7-e47c63d4516316
197832isoniazid 300 MG Oral TabletSCDd5039796-6ba0-4fa8-84f7-e47c63d4516316
197832INH 300 MG Oral TabletSYd5039796-6ba0-4fa8-84f7-e47c63d4516316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0370-05009003700050 TABLET in 1 BOTTLE (50090-0370-0) 50 tablet2018-10-232027-06-30NoNoCurrent
50090-0370-150090037001100 TABLET in 1 BOTTLE (50090-0370-1) 100 tablet2016-06-290000-00-00NoNoCurrent
50090-0370-35009003700330 TABLET in 1 BOTTLE (50090-0370-3) 30 tablet2016-06-292027-06-30NoNoCurrent