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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
V83O1VOZ8LISONIAZID54-85-3ISONIAZID

Packages

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

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Isoniazid Tablets, USPBryant Ranch Prepack2025-10-13HUMAN PRESCRIPTION DRUG LABEL1