Hydrocodone Bitartrate and Homatropine Methylbromide
Hydrocodone Bitartrate and Homatropine Methylbromide Syrup
Approved
Approval ID
95828fad-323e-4510-acbf-6d354b25b887
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-869
Application NumberANDA040613
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Homatropine Methylbromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 21, 2009
FDA Product Classification
INGREDIENTS (12)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
HOMATROPINE METHYLBROMIDEActive
Quantity: 1.5 mg in 5 mL
Code: 68JRS2HC1C
Classification: ACTIB
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT