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FDA Approval

FENTANYL CITRATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

DUNS: 080679498

Effective Date

October 19, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Fentanyl(1200 ug in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

SpecGx LLC

DUNS Number

163205300

Products6

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

FENTANYL CITRATE

Product Details

NDC Product Code

0406-9212

Application Number

ANDA078907

Marketing Category

ANDA (C73584)

Route of Administration

TRANSMUCOSAL

Effective Date

October 19, 2023

Ingredients

SUCROSEInactive

Code: C151H8M554Class: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

Code: MUN5LYG46HClass: ACTIMQuantity: 1200 ug in 1 1

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6TClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FENTANYL CITRATE

Product Details

NDC Product Code

0406-9216

Application Number

ANDA078907

Marketing Category

ANDA (C73584)

Route of Administration

TRANSMUCOSAL

Effective Date

October 19, 2023

Ingredients

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

Code: MUN5LYG46HClass: ACTIMQuantity: 1600 ug in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FENTANYL CITRATE

Product Details

NDC Product Code

0406-9204

Application Number

ANDA078907

Marketing Category

ANDA (C73584)

Route of Administration

TRANSMUCOSAL

Effective Date

October 19, 2023

Ingredients

Code: MUN5LYG46HClass: ACTIMQuantity: 400 ug in 1 1

SUCROSEInactive

Code: C151H8M554Class: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FENTANYL CITRATE

Product Details

NDC Product Code

0406-9202

Application Number

ANDA078907

Marketing Category

ANDA (C73584)

Route of Administration

TRANSMUCOSAL

Effective Date

October 19, 2023

Ingredients

Code: MUN5LYG46HClass: ACTIMQuantity: 200 ug in 1 1

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6TClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FENTANYL CITRATE

Product Details

NDC Product Code

0406-9206

Application Number

ANDA078907

Marketing Category

ANDA (C73584)

Route of Administration

TRANSMUCOSAL

Effective Date

October 19, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

Code: MUN5LYG46HClass: ACTIMQuantity: 600 ug in 1 1

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6TClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

FENTANYL CITRATE

Product Details

NDC Product Code

0406-9208

Application Number

ANDA078907

Marketing Category

ANDA (C73584)

Route of Administration

TRANSMUCOSAL

Effective Date

October 19, 2023

Ingredients

SUCROSEInactive

Code: C151H8M554Class: IACT

Code: MUN5LYG46HClass: ACTIMQuantity: 800 ug in 1 1

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

DEXTRATESInactive

Code: G263MI44RUClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive

Code: GR686LBA74Class: IACT

MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive

Code: 461P5CJN6TClass: IACT

ALCOHOLInactive

Code: 3K9958V90MClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

AMMONIAInactive

Code: 5138Q19F1XClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

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