DICYCLOMINE
Approved
Approval ID
59b1b2cc-73ce-49cf-a87a-05a2d6428be5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2009
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-324
Application NumberANDA040161
Product Classification
M
Marketing Category
C73584
G
Generic Name
DICYCLOMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2009
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 20 mg in 1 1
Code: CQ903KQA31
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT