Hydrocodone Bitartrate and Homatropine Methylbromide
These highlights do not include all the information needed to use HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE safely and effectively. See full prescribing information for HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE.HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE oral solution, for oral administration, CII Initial U.S. Approval: 1943
Approved
Approval ID
9a737416-08e0-4df6-897e-cf9d1b5f0b01
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 19, 2018
Manufacturers
FDA
KVK-Tech, Inc.
DUNS: 173360061
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 oral solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10702-150
Application NumberANDA207487
Product Classification
M
Marketing Category
C73584
G
Generic Name
hydrocodone bitartrate and homatropine methylbromide oral solution
Product Specifications
Route of AdministrationORAL
Effective DateDecember 19, 2018
FDA Product Classification
INGREDIENTS (12)
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 5 mL
Code: NO70W886KK
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
MALTITOLInactive
Code: D65DG142WK
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HOMATROPINE METHYLBROMIDEActive
Quantity: 1.5 mg in 5 mL
Code: 68JRS2HC1C
Classification: ACTIB