EXALGO
These highlights do not include all the information needed to use EXALGO safely and effectively. See full prescribing information for EXALGO. EXALGO (hydromorphone HCl) Extended-Release Tablets, for oral use, CII Initial U.S. Approval: 1984
Approved
Approval ID
0dedd480-dc5c-499c-8763-6044b9bd4a6b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 28, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydromorphone Hydrochloride
PRODUCT DETAILS
NDC Product Code54868-6387
Application NumberNDA021217
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 28, 2013
Generic NameHydromorphone Hydrochloride
INGREDIENTS (14)
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 8 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
Hydromorphone Hydrochloride
PRODUCT DETAILS
NDC Product Code54868-6388
Application NumberNDA021217
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateJanuary 28, 2013
Generic NameHydromorphone Hydrochloride
INGREDIENTS (14)
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYDROMORPHONE HYDROCHLORIDEActive
Quantity: 16 mg in 1 1
Code: L960UP2KRW
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT