Dicyclomine HCl
These highlights do not include all the information needed to use DICYCLOMINE HYDROCHLORIDE INJECTION safely and effectively. See Full Prescribing Information for DICYCLOMINE HYDROCHLORIDE INJECTION. DICYCLOMINE HYDROCHLORIDE injection, for intramuscular use. Initial U.S. Approval: 1950
Approved
Approval ID
be216fa1-e509-4ae5-a62a-550881d090ae
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2023
Manufacturers
FDA
Nexus Pharmaceuticals LLC
DUNS: 620714787
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 Code14789-010
Application NumberANDA206468
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicyclomine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 22, 2023
FDA Product Classification
INGREDIENTS (4)
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: CQ903KQA31
Classification: ACTIB
Dicyclomine HydrochlorideActive
Quantity: 10 mg in 1 mL
Code: CQ903KQA31
Classification: ACTIB