Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine Methylbromide Syrup
Approved
Approval ID
0184de92-e728-4390-95f6-a463f583416a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2011
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.
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5168
Application NumberANDA040613
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (12)
HOMATROPINE METHYLBROMIDEActive
Quantity: 1.5 mg in 5 mL
Code: 68JRS2HC1C
Classification: ACTIB
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT