HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
These highlights do not include all the information needed to use hydrocodone bitartrate and homatropine methylbromide oral solution safely and effectively. See full prescribing information for hydrocodone bitartrate and homatropine methylbromide oral solution. Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution, for oral administration, CII Initial U.S. Approval: 1943
Approved
Approval ID
8d4a9c18-f9e8-4474-8c76-7378bcdcacb6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 16, 2019
Manufacturers
FDA
Bio-Pharm, Inc.
DUNS: 801652546
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 Code59741-262
Application NumberANDA204765
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 16, 2019
FDA Product Classification
INGREDIENTS (12)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HOMATROPINE METHYLBROMIDEActive
Quantity: 1.5 mg in 5 mL
Code: 68JRS2HC1C
Classification: ACTIB
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT