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 capsules, for oral use DICYCLOMINE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1950
Approved
Approval ID
f3a3e5ad-9178-4855-b537-abd125836a07
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2023
Manufacturers
FDA
Preferred Pharmaceuticals, Inc.
DUNS: 791119022
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 Code68788-9525
Application NumberANDA085223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicyclomine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (9)
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
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
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT