Ethambutol
ETHAMBUTOL HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
b2f95b0b-9de3-4c0b-a46e-a7eee6428b4b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 12, 2009
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 Code54868-6219
Application NumberANDA075095
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethambutol hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2011
FDA Product Classification
INGREDIENTS (14)
ETHAMBUTOL HYDROCHLORIDEActive
Quantity: 400 mg in 1 1
Code: QE4VW5FO07
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
RAW SUGARInactive
Code: 8M707QY5GH
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT