Lucemyra
These highlights do not include all the information needed to use LUCEMYRA safely and effectively. See full prescribing information for LUCEMYRA. LUCEMYRA (lofexidine) tablets, for oral use Initial U.S. Approval: 2018
Approved
Approval ID
b748f308-ba71-4fd9-84ec-ec7e0f210885
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
USWM, LLC
DUNS: 117542566
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lofexidine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code78670-050
Application NumberNDA209229
Product Classification
M
Marketing Category
C73594
G
Generic Name
lofexidine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2020
FDA Product Classification
INGREDIENTS (7)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
LOFEXIDINE HYDROCHLORIDEActive
Quantity: 0.2 mg in 1 1
Code: V47G1SDI1B
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
calcium stearateInactive
Code: 776XM7047L
Classification: IACT