Lyrica

These highlights do not include all the information needed to use LYRICA safely and effectively. See full prescribing information for LYRICA. LYRICA (pregabalin) Capsules, CVLYRICA (pregabalin) Oral Solution, CVInitial U.S. Approval: 2004

Approved

Approval ID

8fb45a78-b2d8-45dd-b844-0de21d1fdde9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 28, 2010

Manufacturers

FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-664

Application NumberNDA021446

Product Classification

Marketing Category

C73594

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateMarch 22, 2010

FDA Product Classification

INGREDIENTS (13)

PREGABALINActive

Quantity: 300 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

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

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code21695-278

Application NumberNDA021724

Product Classification

Marketing Category

C73594

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateMarch 22, 2010

FDA Product Classification

INGREDIENTS (13)

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

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code21695-276

Application NumberNDA021724

Product Classification

Marketing Category

C73594

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateMarch 22, 2010

FDA Product Classification

INGREDIENTS (12)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

PREGABALINActive

Quantity: 25 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

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 Code21695-277

Application NumberNDA021724

Product Classification

Marketing Category

C73594

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateMarch 22, 2010

FDA Product Classification

INGREDIENTS (12)

PREGABALINActive

Quantity: 50 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

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 Code21695-661

Application NumberNDA021724

Product Classification

Marketing Category

C73594

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateMarch 22, 2010

FDA Product Classification

INGREDIENTS (11)

PREGABALINActive

Quantity: 100 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

GELATINInactive

Code: 2G86QN327L

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

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code21695-662

Application NumberNDA021724

Product Classification

Marketing Category

C73594

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateMarch 22, 2010

FDA Product Classification

INGREDIENTS (12)

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

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code21695-663

Application NumberNDA021724

Product Classification

Marketing Category

C73594

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateMarch 22, 2010

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

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

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Lyrica

Products 7

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (11)

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