NDC 42747-224

Abstral

Fentanyl

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

• Product ID: 42747-224_d07bb89b-1d6e-43a0-839d-d85a8f0619c5
• NDC: 42747-224
• Product Type: Human Prescription Drug
• Proprietary Name: Abstral
• Generic Name: Fentanyl
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2011-01-07
• Marketing Category: NDA / NDA
• Application Number: NDA022510
• Labeler Name: ProStrakan, Inc.
• Substance Name: FENTANYL CITRATE
• Active Ingredient Strength: 400 ug/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 42747-224-12

12 TABLET in 1 BLISTER PACK (42747-224-12)

• Marketing Start Date: 2011-01-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42747-224-32 [42747022432]

Abstral TABLET

• Marketing Category: NDA
• Application Number: NDA022510
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-01-07
• Inactivation Date: 2019-11-27

NDC 42747-224-12 [42747022412]

Abstral TABLET

• Marketing Category: NDA
• Application Number: NDA022510
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-01-07
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
FENTANYL CITRATE	400 ug/1

OpenFDA Data

• SPL SET ID: 4906457e-30ad-4da7-b3ac-bb9e6651a670
• Manufacturer:
  • ProStrakan, 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" or generic name "Fentanyl"

NDC	Brand Name	Generic Name
42747-226	Abstral	Abstral
42747-222	Abstral	Abstral
42747-224	Abstral	Abstral
42747-221	Abstral	Abstral
42747-223	Abstral	Abstral
42747-228	Abstral	Abstral
57881-338	Abstral	Abstral
57881-336	Abstral	Abstral
57881-332	Abstral	Abstral
57881-333	Abstral	Abstral
57881-334	Abstral	Abstral
57881-331	Abstral	Abstral
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
20482-001	SUBSYS	fentanyl
20482-002	SUBSYS	fentanyl