NDC 20482-016

SUBSYS

Fentanyl

SUBSYS is a Sublingual Spray in the Human Prescription Drug category. It is labeled and distributed by Insys Therapeutics, Inc.. The primary component is Fentanyl.

• Product ID: 20482-016_97f180f5-d865-8c33-e053-2995a90ad465
• NDC: 20482-016
• Product Type: Human Prescription Drug
• Proprietary Name: SUBSYS
• Generic Name: Fentanyl
• Dosage Form: Spray
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2012-08-30
• Marketing Category: NDA / NDA
• Application Number: NDA202788
• Labeler Name: Insys Therapeutics, Inc.
• Substance Name: FENTANYL
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 20482-016-15

15 BLISTER PACK in 1 CARTON (20482-016-15) > 2 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY

• Marketing Start Date: 2012-08-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 20482-016-30 [20482001630]

SUBSYS SPRAY

• Marketing Category: NDA
• Application Number: NDA202788
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-08-30
• Marketing End Date: 2013-05-08

NDC 20482-016-15 [20482001615]

SUBSYS SPRAY

• Marketing Category: NDA
• Application Number: NDA202788
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-08-30

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL	.8 mg/1

OpenFDA Data

• SPL SET ID: 18a413e9-11e0-4a8f-86c0-d33b37b7b771
• Manufacturer:
  • Insys Therapeutics, Inc.
• UNII:
  • UF599785JZ
• RxNorm Concept Unique ID - RxCUI:
  • 1237060
  • 1740010
  • 1237059
  • 1740007
  • 1237068
  • 1237057
  • 1740009
  • 1740008
  • 1237064
  • 1237050
  • 1237066
  • 1237055
  • 1237062
  • 1237070

Pharmacological Class

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

NDC Crossover Matching brand name "SUBSYS" or generic name "Fentanyl"

NDC	Brand Name	Generic Name
20482-001	SUBSYS	fentanyl
20482-002	SUBSYS	fentanyl
20482-012	SUBSYS	SUBSYS
20482-006	SUBSYS	SUBSYS
20482-008	SUBSYS	SUBSYS
20482-004	SUBSYS	SUBSYS
20482-016	SUBSYS	SUBSYS
0378-9119	FENTANYL	FENTANYL
0378-9121	FENTANYL	FENTANYL
0378-9122	FENTANYL	FENTANYL
0378-9123	FENTANYL	FENTANYL
0378-9124	FENTANYL	FENTANYL
0378-9125	FENTANYL	FENTANYL
0378-9126	FENTANYL	FENTANYL
0378-9127	FENTANYL	FENTANYL
0591-3198	Fentanyl	Fentanyl
0591-3212	Fentanyl	Fentanyl
0591-3213	Fentanyl	Fentanyl
0591-3214	Fentanyl	Fentanyl
0781-7240	Fentanyl	Fentanyl
0781-7241	Fentanyl	Fentanyl
0781-7242	Fentanyl	Fentanyl
0781-7243	Fentanyl	Fentanyl
0781-7244	Fentanyl	Fentanyl