Dicyclomine Hydrochloride
Dicyclomine Hydrochloride Tablets, USPDicyclomine Hydrochloride Capsules, USPRx Only
Approved
Approval ID
54582bac-9386-4070-bfce-8c392172d24d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-0033
Application NumberANDA084285
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicyclomine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2011
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DICYCLOMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: CQ903KQA31
Classification: ACTIB
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT