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Transmucosal Fentanyl Citrate

These highlights do not include all the information needed to use Oral Transmucosal Fentanyl Citrate (OTFC) safely and effectively. See full prescribing information for OTFC. Oral Transmucosal Fentanyl Citrate (OTFC) (fentanyl citrate) oral transmucosal lozenge, CII Initial U.S. Approval: 1968

Approved
Approval ID

e4ce209d-3f8c-4ac4-bec1-2525a93708bc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 6, 2011

Manufacturers
FDA

H.J. Harkins Company, Inc.

DUNS: 147681894

Products 3

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 Code52959-548
Application NumberNDA020747
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationORAL, TRANSMUCOSAL
Effective DateSeptember 6, 2011
FDA Product Classification

INGREDIENTS (7)

DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
FENTANYL CITRATEActive
Quantity: 600 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT

fentanyl citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52959-566
Application NumberNDA020747
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationORAL, TRANSMUCOSAL
Effective DateSeptember 6, 2011
FDA Product Classification

INGREDIENTS (7)

FENTANYL CITRATEActive
Quantity: 1200 1 in 1 1
Code: MUN5LYG46H
Classification: ACTIM
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT

fentanyl citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code52959-549
Application NumberNDA020747
Product Classification
M
Marketing Category
C73594
G
Generic Name
fentanyl citrate
Product Specifications
Route of AdministrationORAL, TRANSMUCOSAL
Effective DateSeptember 6, 2011
FDA Product Classification

INGREDIENTS (7)

FENTANYL CITRATEActive
Quantity: 400 ug in 1 1
Code: MUN5LYG46H
Classification: ACTIM
DEXTRATESInactive
Code: G263MI44RU
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT

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Transmucosal Fentanyl Citrate - FDA Drug Approval Details