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. DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
Approved
Approval ID
ceba627b-5fe2-4ab3-b3bc-d90c3a170a93
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
TWi Pharmaceuticals, Inc.
DUNS: 658402052
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 Code24979-200
Application NumberANDA216782
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 2, 2023
Generic NameDicyclomine Hydrochloride
INGREDIENTS (7)
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: CQ903KQA31
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT