Ethambutol Hydrochloride
ETHAMBUTOL HYDROCHLORIDE TABLETS USP
Approved
Approval ID
c732b415-e1f9-478f-896d-1dc8b6362da4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2024
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-281
Application NumberANDA078939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethambutol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (11)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ETHAMBUTOL HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
Ethambutol Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-280
Application NumberANDA078939
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethambutol Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2024
FDA Product Classification
INGREDIENTS (11)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ETHAMBUTOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB