ETHAMBUTOL HYDROCHLORIDE
ETHAMBUTOL HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
08decdf3-a397-42e7-8ac3-e489c0cc7085
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
Epic Pharma, LLC
DUNS: 827915443
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 Code42806-102
Application NumberANDA075095
Product Classification
M
Marketing Category
C73584
G
Generic Name
ETHAMBUTOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2020
FDA Product Classification
INGREDIENTS (14)
ETHAMBUTOL HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
ETHAMBUTOL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-101
Application NumberANDA075095
Product Classification
M
Marketing Category
C73584
G
Generic Name
ETHAMBUTOL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 30, 2020
FDA Product Classification
INGREDIENTS (14)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ETHAMBUTOL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT