Dicyclomine hydrochloride
DICYCLOMINE HYDROCHLORIDE, USP. These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE, USP safely and effectively. See full prescribing information for DICYCLOMINE HYDROCHLORIDE, USP. DICYCLOMINE HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1950
Approved
Approval ID
01413a77-48f8-1a8a-e063-6394a90ae494
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 24, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
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 Code51407-783
Application NumberANDA040204
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicyclomine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 24, 2023
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: CQ903KQA31
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT