Ethambutol Hydrochloride
Ethambutol HydrochlorideTABLETS USP100 mg and 400 mg
Approved
Approval ID
d123fbd1-57de-47c6-963f-54d69427290b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 16, 2012
Manufacturers
FDA
STI Pharma
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 Code68850-004
Application NumberNDA016320
Product Classification
M
Marketing Category
C73605
G
Generic Name
Ethambutol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2011
FDA Product Classification
INGREDIENTS (9)
Ethambutol HydrochlorideActive
Quantity: 100 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Ethambutol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68850-005
Application NumberNDA016320
Product Classification
M
Marketing Category
C73605
G
Generic Name
Ethambutol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2011
FDA Product Classification
INGREDIENTS (9)
Ethambutol HydrochlorideActive
Quantity: 400 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
Sodium Lauryl SulfateInactive
Code: 368GB5141J
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Stearic AcidInactive
Code: 4ELV7Z65AP
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT