Cevimeline Hydrochloride
CEVIMELINE HYDROCHLORIDE CAPSULES
Approved
Approval ID
51307f82-66f2-41c7-80ff-174d7e50f7ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cevimeline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9863
Application NumberANDA203775
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cevimeline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2018
FDA Product Classification
INGREDIENTS (4)
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIR
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT