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 tablets, for oral administration, CII Initial U.S. Approval: 1943
Approved
Approval ID
26d7c90c-5e6b-4bdb-b06f-c76173a01c21
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
PRODUCT DETAILS
NDC Product Code10702-055
Application NumberANDA207176
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 19, 2018
Generic NameHydrocodone Bitartrate and Homatropine Methylbromide
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HOMATROPINE METHYLBROMIDEActive
Quantity: 1.5 mg in 1 1
Code: 68JRS2HC1C
Classification: ACTIB