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Fentanyl Citrate

Fentanyl Citrate 20 mcg/mL in 0.9% Sodium Chloride 30 mL PCA Vial, Non-MedNet

Approved
Approval ID

f936818a-b0bd-4811-b9b8-3fa9620a7379

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 6, 2014

Manufacturers
FDA

Cantrell Drug Company

DUNS: 035545763

Products 1

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 Code52533-025
Product Classification
G
Generic Name
Fentanyl Citrate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 13, 2014
FDA Product Classification

INGREDIENTS (5)

FENTANYL CITRATEActive
Quantity: 20 ug in 1 mL
Code: MUN5LYG46H
Classification: ACTIM
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium ChlorideInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: CNTM
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM

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Fentanyl Citrate - FDA Drug Approval Details