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

65d9e751-61c2-4741-85c0-2526cfdc765c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 8, 2023

Manufacturers

FDA

Eskayef Pharmaceuticals Limited

DUNS: 731689068

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 Code72658-0812

Application NumberANDA212988

Product Classification

Marketing Category

C73584

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateAugust 8, 2023

FDA Product Classification

INGREDIENTS (12)

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

PREGABALINActive

Quantity: 150 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72658-0849

Application NumberANDA212988

Product Classification

Marketing Category

C73584

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateAugust 8, 2023

FDA Product Classification

INGREDIENTS (13)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

WATERInactive

Code: 059QF0KO0R

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

PREGABALINActive

Quantity: 200 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72658-0810

Application NumberANDA212988

Product Classification

Marketing Category

C73584

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateAugust 8, 2023

FDA Product Classification

INGREDIENTS (13)

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PREGABALINActive

Quantity: 75 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72658-0809

Application NumberANDA212988

Product Classification

Marketing Category

C73584

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateAugust 8, 2023

FDA Product Classification

INGREDIENTS (12)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PREGABALINActive

Quantity: 50 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72658-0808

Application NumberANDA212988

Product Classification

Marketing Category

C73584

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateAugust 8, 2023

FDA Product Classification

INGREDIENTS (12)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

PREGABALINActive

Quantity: 25 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72658-0811

Application NumberANDA212988

Product Classification

Marketing Category

C73584

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateAugust 8, 2023

FDA Product Classification

INGREDIENTS (13)

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

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

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

PREGABALINActive

Quantity: 100 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72658-0814

Application NumberANDA212988

Product Classification

Marketing Category

C73584

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateAugust 8, 2023

FDA Product Classification

INGREDIENTS (13)

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

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

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

PREGABALINActive

Quantity: 300 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

PREGABALIN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code72658-0813

Application NumberANDA212988

Product Classification

Marketing Category

C73584

Generic Name

PREGABALIN

Product Specifications

Route of AdministrationORAL

Effective DateAugust 8, 2023

FDA Product Classification

INGREDIENTS (13)

GELATINInactive

Code: 2G86QN327L

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

PREGABALINActive

Quantity: 225 mg in 1 1

Code: 55JG375S6M

Classification: ACTIB

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

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PREGABALIN

Products 8

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (12)

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 (13)

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

PREGABALIN

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (13)

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