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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6387
Application NumberNDA021217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2013
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6388
Application NumberNDA021217
Product Classification
M
Marketing Category
C73594
G
Generic Name
Hydromorphone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 28, 2013
FDA Product Classification
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