NDC 42358-800

Abstral fentanyl

Fentanyl Citrate

Abstral fentanyl is a Sublingual Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Sentynl Therapeutics, Inc.. The primary component is Fentanyl Citrate.

• Product ID: 42358-800_463c068d-9e51-43c7-8d01-116947effb42
• NDC: 42358-800
• Product Type: Human Prescription Drug
• Proprietary Name: Abstral fentanyl
• Generic Name: Fentanyl Citrate
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2016-10-01
• Marketing Category: NDA / NDA
• Application Number: NDA022510
• Labeler Name: Sentynl Therapeutics, Inc.
• Substance Name: FENTANYL CITRATE
• Active Ingredient Strength: 800 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 42358-800-32

8 BLISTER PACK in 1 CARTON (42358-800-32) > 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

• Marketing Start Date: 2016-10-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42358-800-32 [42358080032]

Abstral fentanyl TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA022510
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-01
• Marketing End Date: 2020-06-30

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL CITRATE	800 ug/1

OpenFDA Data

• SPL SET ID: e60f00e9-2cf4-4c20-b570-1c2ea426c8c7
• Manufacturer:
  • Sentynl Therapeutics, Inc.
• UNII:
  • MUN5LYG46H
• RxNorm Concept Unique ID - RxCUI:
  • 1053652
  • 1053651
  • 1053658
  • 1053657
  • 1053655
  • 1053654
  • 1053661
  • 1053663
  • 1053660
  • 1053647
  • 1053666
  • 1053664

Pharmacological Class

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

NDC Crossover Matching brand name "Abstral fentanyl" or generic name "Fentanyl Citrate"

NDC	Brand Name	Generic Name
42358-300	Abstral fentanyl	Abstral fentanyl
42358-100	Abstral fentanyl	Abstral fentanyl
42358-400	Abstral fentanyl	Abstral fentanyl
42358-800	Abstral fentanyl	Abstral fentanyl
42358-200	Abstral fentanyl	Abstral fentanyl
42358-600	Abstral fentanyl	Abstral fentanyl
0093-7865	Fentanyl Citrate	Fentanyl Citrate
0093-7866	Fentanyl Citrate	Fentanyl Citrate
0093-7867	Fentanyl Citrate	Fentanyl Citrate
0093-7868	Fentanyl Citrate	Fentanyl Citrate
0093-7869	Fentanyl Citrate	Fentanyl Citrate
0093-7870	Fentanyl Citrate	Fentanyl Citrate
0406-9202	FENTANYL CITRATE	FENTANYL CITRATE