FDA.reportPublic FDA data

Isoniazid

Product NDC
70518-4315
11-digit product format
705184315
Labeler code
70518
Product ID
70518-4315_47a3beb8-c45f-fe9c-e063-6394a90a21fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA080937
Marketing category
ANDA
Marketing start
2025-03-20
Marketing end
2028-02-28
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
70518-4315-0Isoniazid30 in 1 BLISTER PACKTABLET306
70518-4315-1Isoniazid30 in 1 BOTTLE, PLASTICTABLET306
70518-4315-2Isoniazid45 in 1 BOTTLE, PLASTICTABLET456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4315ISONIAZID TABLET [REMEDYREPACK INC.]4Current NDC, 3 package rows20250522_6dab7b7b-a3a9-47ef-b423-134bc6970d8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSN6dab7b7b-a3a9-47ef-b423-134bc6970d8b6
197832isoniazid 300 MG Oral TabletSCD6dab7b7b-a3a9-47ef-b423-134bc6970d8b6
197832INH 300 MG Oral TabletSY6dab7b7b-a3a9-47ef-b423-134bc6970d8b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-4315-07051843150030 TABLET in 1 BLISTER PACK (70518-4315-0) 30 tablet2025-03-202028-02-28NoNoHistorical
70518-4315-17051843150130 TABLET in 1 BOTTLE, PLASTIC (70518-4315-1) 30 tablet2025-05-012028-02-28NoNoHistorical
70518-4315-27051843150245 TABLET in 1 BOTTLE, PLASTIC (70518-4315-2) 45 tablet2025-05-122028-02-28NoNoHistorical