Isoniazid

Product NDC
71335-3083
11-digit product format
713353083
Labeler code
71335
Product ID
71335-3083_8a54747c-67c0-42c9-bc36-bea05101c811
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA080936
Marketing category
ANDA
Marketing start
2024-11-01
Marketing end
2027-12-31
Substance
ISONIAZID
Active strength
100 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
ISONIAZID100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV83O1VOZ8L
Rxcui311166

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
71335-3083-1Isoniazid30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311166isoniazid 100 MG Oral TabletPSN03bf3bd5-64f9-4491-89fd-96c5c10d01291
311166isoniazid 100 MG Oral TabletSCD03bf3bd5-64f9-4491-89fd-96c5c10d01291
311166INH 100 MG Oral TabletSY03bf3bd5-64f9-4491-89fd-96c5c10d01291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-3083-17133530830130 TABLET in 1 BOTTLE (71335-3083-1) 30 tablet2026-02-162027-12-31NoNoHistorical