Pregabalin
These highlights do not include all the information needed to use PREGABALIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for PREGABALIN EXTENDED-RELEASE TABLETS.PREGABALIN extended-release tablets, for oral use, CVInitial U.S. Approval: 2004
Approved
Approval ID
1ffa4233-c168-4d03-892b-d48051b55a0a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2022
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 3
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 Code63304-048
Application NumberANDA211889
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (13)
PREGABALINActive
Quantity: 165 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-047
Application NumberANDA211889
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (13)
PREGABALINActive
Quantity: 82.5 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Pregabalin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-049
Application NumberANDA211889
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pregabalin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (13)
PREGABALINActive
Quantity: 330 mg in 1 1
Code: 55JG375S6M
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: F68VH75CJC
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT