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, CV Initial U.S. Approval: 2004
Approved
Approval ID
170c0c95-2ee8-4dff-bbd6-b87a21e8cf81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 5, 2023
Manufacturers
FDA
Cadila Pharmaceuticals Limited
DUNS: 862257719
Products 8
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 Code71209-032
Application NumberANDA206452
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (10)
PREGABALINActive
Quantity: 25 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PREGABALIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-033
Application NumberANDA206452
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (10)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PREGABALINActive
Quantity: 50 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PREGABALIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-036
Application NumberANDA206452
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (10)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PREGABALINActive
Quantity: 150 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PREGABALIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-039
Application NumberANDA206452
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PREGABALINActive
Quantity: 300 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PREGABALIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-034
Application NumberANDA206452
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (11)
PREGABALINActive
Quantity: 75 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PREGABALIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-038
Application NumberANDA206452
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (11)
PREGABALINActive
Quantity: 225 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
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
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PREGABALIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-035
Application NumberANDA206452
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (11)
PREGABALINActive
Quantity: 100 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PREGABALIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71209-037
Application NumberANDA206452
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREGABALIN
Product Specifications
Route of AdministrationORAL
Effective DateMay 5, 2023
FDA Product Classification
INGREDIENTS (11)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PREGABALINActive
Quantity: 200 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT