Dicyclomine
These highlights do not include all the information needed to use BENTYL safely and effectively. See full prescribing information for dicyclomine hydrochloride.Dicyclomine Hydrochloride Capsules, USP for oral useDicyclomine Hydrochloride Tablets, USP for oral use Initial U.S. Approval: 1950
Approved
Approval ID
aa8350bd-f832-4983-baed-2a6978819b49
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 2, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-221
Application NumberANDA040161
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicyclomine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2012
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: CQ903KQA31
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT