Cevimeline Hydrochloride
Cevimeline Hydrochloride Capsules
Approved
Approval ID
fe30c870-a060-4a5b-ae61-6a9933854419
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 Code71335-2264
Application NumberANDA091591
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cevimeline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 25, 2018
FDA Product Classification
INGREDIENTS (9)
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIR
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT