Myambutol
Myambutol (Ethambutol Hydrochloride Tablets, USP)
Approved
Approval ID
b362b3cd-2c26-4af5-baa4-084217729fa5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2022
Manufacturers
FDA
STI Pharma, LLC
DUNS: 959657511
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ethambutol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68850-012
Application NumberNDA016320
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ethambutol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2022
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ETHAMBUTOL HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
Ethambutol hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68850-010
Application NumberNDA016320
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ethambutol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2022
FDA Product Classification
INGREDIENTS (6)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ETHAMBUTOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB