FENTANYL CITRATE

These highlights do not include all the information needed to use ORAL TRANSMUCOSAL FENTANYL CITRATE safely and effectively. See full prescribing information for ORAL TRANSMUCOSAL FENTANYL CITRATE. ORAL TRANSMUCOSAL FENTANYL CITRATE , oral transmucosal lozenge, CII Initial U.S. Approval: 1968

Approved

Approval ID

552ba162-76ed-4bc9-8c2c-fac7a1804da0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 19, 2023

Manufacturers

FDA

SpecGx LLC

DUNS: 080679498

Products 6

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

FENTANYL CITRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-9212

Application NumberANDA078907

Product Classification

Marketing Category

C73584

Generic Name

FENTANYL CITRATE

Product Specifications

Route of AdministrationTRANSMUCOSAL

Effective DateOctober 19, 2023

FDA Product Classification

INGREDIENTS (14)

SUCROSEInactive

Code: C151H8M554

Classification: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FENTANYL CITRATEActive

Quantity: 1200 ug in 1 1

Code: MUN5LYG46H

Classification: ACTIM

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DEXTRATESInactive

Code: G263MI44RU

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FENTANYL CITRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-9216

Application NumberANDA078907

Product Classification

Marketing Category

C73584

Generic Name

FENTANYL CITRATE

Product Specifications

Route of AdministrationTRANSMUCOSAL

Effective DateOctober 19, 2023

FDA Product Classification

INGREDIENTS (14)

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

DEXTRATESInactive

Code: G263MI44RU

Classification: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FENTANYL CITRATEActive

Quantity: 1600 ug in 1 1

Code: MUN5LYG46H

Classification: ACTIM

SUCROSEInactive

Code: C151H8M554

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FENTANYL CITRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-9204

Application NumberANDA078907

Product Classification

Marketing Category

C73584

Generic Name

FENTANYL CITRATE

Product Specifications

Route of AdministrationTRANSMUCOSAL

Effective DateOctober 19, 2023

FDA Product Classification

INGREDIENTS (14)

FENTANYL CITRATEActive

Quantity: 400 ug in 1 1

Code: MUN5LYG46H

Classification: ACTIM

SUCROSEInactive

Code: C151H8M554

Classification: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

DEXTRATESInactive

Code: G263MI44RU

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FENTANYL CITRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-9202

Application NumberANDA078907

Product Classification

Marketing Category

C73584

Generic Name

FENTANYL CITRATE

Product Specifications

Route of AdministrationTRANSMUCOSAL

Effective DateOctober 19, 2023

FDA Product Classification

INGREDIENTS (14)

FENTANYL CITRATEActive

Quantity: 200 ug in 1 1

Code: MUN5LYG46H

Classification: ACTIM

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DEXTRATESInactive

Code: G263MI44RU

Classification: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FENTANYL CITRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-9206

Application NumberANDA078907

Product Classification

Marketing Category

C73584

Generic Name

FENTANYL CITRATE

Product Specifications

Route of AdministrationTRANSMUCOSAL

Effective DateOctober 19, 2023

FDA Product Classification

INGREDIENTS (14)

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DEXTRATESInactive

Code: G263MI44RU

Classification: IACT

FENTANYL CITRATEActive

Quantity: 600 ug in 1 1

Code: MUN5LYG46H

Classification: ACTIM

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

FENTANYL CITRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code0406-9208

Application NumberANDA078907

Product Classification

Marketing Category

C73584

Generic Name

FENTANYL CITRATE

Product Specifications

Route of AdministrationTRANSMUCOSAL

Effective DateOctober 19, 2023

FDA Product Classification

INGREDIENTS (14)

SUCROSEInactive

Code: C151H8M554

Classification: IACT

FENTANYL CITRATEActive

Quantity: 800 ug in 1 1

Code: MUN5LYG46H

Classification: ACTIM

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QP

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DEXTRATESInactive

Code: G263MI44RU

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74

Classification: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6T

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

WATERInactive

Code: 059QF0KO0R

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

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FENTANYL CITRATE

Products 6

FENTANYL CITRATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

FENTANYL CITRATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

FENTANYL CITRATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

FENTANYL CITRATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

FENTANYL CITRATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

FENTANYL CITRATE

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

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