Pregabalin
These highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN Capsules, for oral use CVInitial U.S. Approval: 2004
Approved
Approval ID
62aa850d-199c-44d5-a730-45f43efa850e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2021
Manufacturers
FDA
Tris Pharma Inc
DUNS: 947472119
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-240
Application NumberANDA214322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PREGABALINActive
Quantity: 225 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-235
Application NumberANDA214322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PREGABALINActive
Quantity: 50 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-238
Application NumberANDA214322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (9)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PREGABALINActive
Quantity: 150 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-239
Application NumberANDA214322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (10)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PREGABALINActive
Quantity: 200 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-237
Application NumberANDA214322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (10)
PREGABALINActive
Quantity: 100 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-241
Application NumberANDA214322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (10)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PREGABALINActive
Quantity: 300 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-236
Application NumberANDA214322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (10)
PREGABALINActive
Quantity: 75 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT