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
031f843b-9251-49c7-b2e7-be4cbd2e2295
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2020
Manufacturers
FDA
CELLTRION USA, INC.
DUNS: 116587378
Products 4
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 Code72606-006
Application NumberANDA212865
Product Classification
M
Marketing Category
C73584
G
Generic Name
pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2020
FDA Product Classification
INGREDIENTS (13)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PREGABALINActive
Quantity: 75 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
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
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72606-005
Application NumberANDA212865
Product Classification
M
Marketing Category
C73584
G
Generic Name
pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2020
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
PREGABALINActive
Quantity: 50 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72606-008
Application NumberANDA212865
Product Classification
M
Marketing Category
C73584
G
Generic Name
pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2020
FDA Product Classification
INGREDIENTS (12)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PREGABALINActive
Quantity: 150 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
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
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72606-007
Application NumberANDA212865
Product Classification
M
Marketing Category
C73584
G
Generic Name
pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2020
FDA Product Classification
INGREDIENTS (14)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
PREGABALINActive
Quantity: 100 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT