Hydromet
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . H Y D ROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution, CII Initial U.S. Approval: 1943
Approved
Approval ID
a324c912-a3ef-4296-b9a8-b0fec687eb06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2022
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
hydrocodone bitartrate and homatropine methylbromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0472-1030
Application NumberANDA088017
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocodone bitartrate and homatropine methylbromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2022
FDA Product Classification
INGREDIENTS (14)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HOMATROPINE METHYLBROMIDEActive
Quantity: 1.5 mg in 5 mL
Code: 68JRS2HC1C
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT