Isoniazid

Product NDC
71335-2800
11-digit product format
713352800
Labeler code
71335
Product ID
71335-2800_b2662f53-4b10-4d41-b868-3515e50d9956
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

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
71335-2800-1Isoniazid100 in 1 BOTTLETABLET1001
71335-2800-2Isoniazid30 in 1 BOTTLETABLET301
71335-2800-3Isoniazid60 in 1 BOTTLETABLET601
71335-2800-4Isoniazid35 in 1 BOTTLETABLET351
71335-2800-5Isoniazid90 in 1 BOTTLETABLET901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197832isoniazid 300 MG Oral TabletPSNb6d6dccc-2577-4bbb-896e-5f75b65ee6ca1
197832isoniazid 300 MG Oral TabletSCDb6d6dccc-2577-4bbb-896e-5f75b65ee6ca1
197832INH 300 MG Oral TabletSYb6d6dccc-2577-4bbb-896e-5f75b65ee6ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2800-171335280001100 TABLET in 1 BOTTLE (71335-2800-1) 100 tablet2025-10-132028-02-28NoNoHistorical
71335-2800-27133528000230 TABLET in 1 BOTTLE (71335-2800-2) 30 tablet2025-10-132028-02-28NoNoHistorical
71335-2800-37133528000360 TABLET in 1 BOTTLE (71335-2800-3) 60 tablet2025-10-132028-02-28NoNoHistorical
71335-2800-47133528000435 TABLET in 1 BOTTLE (71335-2800-4) 35 tablet2025-10-132028-02-28NoNoHistorical
71335-2800-57133528000590 TABLET in 1 BOTTLE (71335-2800-5) 90 tablet2025-10-132028-02-28NoNoHistorical