NDC 65293-011

IONSYS

Fentanyl Iontophoretic Transdermal System

IONSYS is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by The Medicines Company. The primary component is Fentanyl Hydrochloride.

• Product ID: 65293-011_45eac440-fb43-3509-e054-00144ff8d46c
• NDC: 65293-011
• Product Type: Human Prescription Drug
• Proprietary Name: IONSYS
• Generic Name: Fentanyl Iontophoretic Transdermal System
• Dosage Form: Patch
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2015-06-01
• Marketing Category: NDA / NDA
• Application Number: NDA021338
• Labeler Name: The Medicines Company
• Substance Name: FENTANYL HYDROCHLORIDE
• Active Ingredient Strength: 40 ug/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65293-011-06

6 TRAY in 1 CARTON (65293-011-06) > 1 POUCH in 1 TRAY (65293-011-01) > 1 PATCH in 1 POUCH

• Marketing Start Date: 2015-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65293-011-01 [65293001101]

IONSYS PATCH

• Marketing Category: NDA
• Application Number: NDA021338
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-06-01
• Marketing End Date: 2020-01-15

NDC 65293-011-06 [65293001106]

IONSYS PATCH

• Marketing Category: NDA
• Application Number: NDA021338
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-06-01
• Marketing End Date: 2020-01-15
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-11

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL HYDROCHLORIDE	40 ug/1

OpenFDA Data

• SPL SET ID: e95afc93-130c-4715-a4f8-ed2de904e2d2
• Manufacturer:
  • The Medicines Company
• UNII:
  • 59H156XY46
• RxNorm Concept Unique ID - RxCUI:
  • 1666837
  • 1666831

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]