Dicyclomine Hydrochloride
These highlights do not include all the information needed to use dicyclomine hydrochloride safely and effectively. See full prescribing information for dicyclomine hydrochloride.
Approved
Approval ID
baae1478-e5e8-44d1-bb8a-9f456861491f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 5, 2013
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dicyclomine Hydrochloride
PRODUCT DETAILS
NDC Product Code66336-911
Application NumberANDA085082
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 5, 2013
Generic NameDicyclomine Hydrochloride
INGREDIENTS (9)
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: CQ903KQA31
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT