LYRICA
These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CVLYRICA (pregabalin) Oral Solution, CVInitial U.S. Approval: 2004
Approved
Approval ID
cae9b2b3-656a-4813-af77-b7644879d2ab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 8, 2013
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PREGABALIN
PRODUCT DETAILS
NDC Product Code16590-503
Application NumberNDA021724
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 8, 2013
Generic NamePREGABALIN
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PREGABALINActive
Quantity: 50 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT