Myambutol
Approved
Approval ID
3d523d8a-a5b8-44eb-8575-e36f186602a3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-2876
Application NumberNDA016320
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ethambutol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2012
FDA Product Classification
INGREDIENTS (9)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ETHAMBUTOL HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT