Isoniazid

Product NDC
64950-217
11-digit product format
649500217
Labeler code
64950
Product ID
64950-217_6ea58bc8-a5a8-47a1-81e1-f769924e1502
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Genus Lifesciences
Application
ANDA080937
Marketing category
ANDA
Marketing start
2024-11-01
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, 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
64950-217-03Isoniazid30 in 1 BOTTLETABLET304
64950-217-10Isoniazid100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-217-03EA - Each64950-217e4390e2e-7194-4433-8e9e-48eba1c5d99912024-12-10
64950-217-10EA - Each64950-21785bdf0f0-4a64-4dad-aa70-25c79f7c843d12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-217ISONIAZID TABLET [GENUS LIFESCIENCES]3Current NDC, 2 package rows20250331_f0b46d1d-2300-457d-a7bd-a88a3f8d2235.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSN9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c101
197832isoniazid 300 MG Oral TabletSCD9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c101
197832INH 300 MG Oral TabletSY9dbaacc4-ed2a-4a9b-83a9-c001d3d9f71c101
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
311166isoniazid 100 MG Oral TabletPSNf0b46d1d-2300-457d-a7bd-a88a3f8d22354
197832isoniazid 300 MG Oral TabletPSNf0b46d1d-2300-457d-a7bd-a88a3f8d22354
311166isoniazid 100 MG Oral TabletSCDf0b46d1d-2300-457d-a7bd-a88a3f8d22354
197832isoniazid 300 MG Oral TabletSCDf0b46d1d-2300-457d-a7bd-a88a3f8d22354
311166INH 100 MG Oral TabletSYf0b46d1d-2300-457d-a7bd-a88a3f8d22354
197832INH 300 MG Oral TabletSYf0b46d1d-2300-457d-a7bd-a88a3f8d22354
197832isoniazid 300 MG Oral TabletPSN38f4c4af-81da-9b0c-e063-6294a90a8b9d1
197832isoniazid 300 MG Oral TabletPSNb6d6dccc-2577-4bbb-896e-5f75b65ee6ca1
197832isoniazid 300 MG Oral TabletSCDb6d6dccc-2577-4bbb-896e-5f75b65ee6ca1
197832isoniazid 300 MG Oral TabletSCD38f4c4af-81da-9b0c-e063-6294a90a8b9d1
197832INH 300 MG Oral TabletSYb6d6dccc-2577-4bbb-896e-5f75b65ee6ca1
197832INH 300 MG Oral TabletSY38f4c4af-81da-9b0c-e063-6294a90a8b9d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64950-217-036495002170330 TABLET in 1 BOTTLE (64950-217-03) 30 tablet2024-11-012027-12-31NoNoHistorical
64950-217-1064950021710100 TABLET in 1 BOTTLE (64950-217-10) 100 tablet2024-11-012028-02-28NoNoHistorical