Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE 10mg caps
Approved
Approval ID
b9466716-e359-294c-e053-2a95a90af708
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
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 Code67296-1409
Application NumberANDA040204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicyclomine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2021
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: CQ903KQA31
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT