Dicyclomine Hydrochloride
70010341Dicyclomine HClCapsules USPDicyclomine HClTablets USPRevised: May 2003Rx only
Approved
Approval ID
ad7e6eaa-42b8-45fd-aca4-e4b64a9ef20f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2019
Manufacturers
FDA
Lake Erie Medical DBA Quality Care Products LLC
DUNS: 831276758
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 Code49999-081
Application NumberANDA085223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dicyclomine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2017
FDA Product Classification
INGREDIENTS (8)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
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
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT