dicyclomine hydrochloride
DICYCLOMINE (dicyclomine hydrochloride) capsule
Approved
Approval ID
ddc61a17-0577-47dc-b323-05e2594a09e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2009
Manufacturers
FDA
Stat Rx USA
DUNS: 786036330
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 Code16590-077
Application NumberANDA040204
Product Classification
M
Marketing Category
C73584
G
Generic Name
dicyclomine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (3)
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: CQ903KQA31
Classification: ACTIB
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT