Isoniazid

Product NDC
67046-1570
11-digit product format
670461570
Labeler code
67046
Product ID
67046-1570_38f4c415-37a4-9c77-e063-6394a90a7012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Isoniazid
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA080937
Marketing category
ANDA
Marketing start
2025-07-02
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
67046-1570-36704615700330 TABLET in 1 BLISTER PACK (67046-1570-3) 30 tablet2025-07-022028-02-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Isoniazid Tablets, USPCoupler LLC2025-07-02HUMAN PRESCRIPTION DRUG LABEL1