Cevimeline Hydrochloride
Cevimeline Hydrochloride Capsules Rx only
Approved
Approval ID
d08d8aa5-76a4-417a-a308-7d195865522f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code59651-422
Application NumberANDA215056
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cevimeline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 2, 2022
FDA Product Classification
INGREDIENTS (9)
CEVIMELINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: P81Q6V85NP
Classification: ACTIR
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT