Pregabalin
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . PREGABALIN Capsules, Initial U.S. Approval: 2004
Approved
Approval ID
c4dcdc54-3902-04e8-8516-30ec13bdf03c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2024
Manufacturers
FDA
ApotexCorp
DUNS: 845263701
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 Code60505-3795
Application NumberANDA211685
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PREGABALINActive
Quantity: 75 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3794
Application NumberANDA211685
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (10)
PREGABALINActive
Quantity: 50 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3796
Application NumberANDA211685
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (11)
PREGABALINActive
Quantity: 100 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3798
Application NumberANDA211685
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (11)
PREGABALINActive
Quantity: 200 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3800
Application NumberANDA211685
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (11)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PREGABALINActive
Quantity: 300 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
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 Code60505-3799
Application NumberANDA211685
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PREGABALINActive
Quantity: 225 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
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
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60505-3793
Application NumberANDA211685
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (10)
PREGABALINActive
Quantity: 25 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
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 Code60505-3797
Application NumberANDA211685
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 17, 2024
FDA Product Classification
INGREDIENTS (10)
PREGABALINActive
Quantity: 150 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT