57881-331 : Abstral 0.1 mg Sublingual Tablet


NDC57881-331
Labeler: Galena Biopharma, Inc.
Product Type: Human Prescription Drug
Drug Name:  Abstral
Dosage Form: Sublingual Tablet
Application #: NDA022510
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 1
Shapes:  Round
Colors:  Blue
Size (mm): 10
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 57881-331-32: 8 BLISTER PACK IN 1 CARTON (57881‑331‑32) > 4 TABLET IN 1 BLISTER PACK (57881‑331‑04)

Active Ingredients:

  • Fentanyl Citrate

Dosage Strength:

  • 100 ug/1

Inactive Ingredients:

  • Croscarmellose Sodium
  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 57881-332 Abstral 0.2 mg Sublingual Tablet by Galena Biopharma, Inc.
  • 57881-333 Abstral 0.3 mg Sublingual Tablet by Galena Biopharma, Inc.
  • 57881-334 Abstral 0.4 mg Sublingual Tablet by Galena Biopharma, Inc.
  • 57881-336 Abstral 0.6 mg Sublingual Tablet by Galena Biopharma, Inc.
  • 57881-338 Abstral 0.8 mg Sublingual Tablet by Galena Biopharma, Inc.
  • 42747-221 Abstral 0.1 mg Sublingual Tablet by Prostrakan, Inc.
  • 42747-222 Abstral 0.2 mg Sublingual Tablet by Prostrakan, Inc.
  • 42747-223 Abstral 0.3 mg Sublingual Tablet by Prostrakan, Inc.
  • 42747-224 Abstral 0.4 mg Sublingual Tablet by Prostrakan, Inc.
  • 42747-226 Abstral 0.6 mg Sublingual Tablet by Prostrakan, Inc.
  • 42747-228 Abstral 0.8 mg Sublingual Tablet by Prostrakan, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 57881-331 QR Code

< Prev: 57869-123Next: 57881-332 >

Related Discussions:

Fentanyl Citrate Powder...Made into a Compound Cream
Hello- I have had stage 4 breast cancer and a Bone Marrow Transplant, double Mastectomies, total Hysterectomy, 7 months ... 1 reply
ACTIQ (fentanyl citrate lozenge)
A sucker/lozenge for pain management ## This is a narcotic pain medication product, Actiq pops contain Fentanyl, (Durage... 3 replies
Fentanyl Withdrawal Symptoms
I'm trying to wean myself off the Fentanyl patch. I went from 75 micro-gms to 50 now I'm on 25. Having a problem... 1667 replies
FENTANYL 50 MCG/HOUR TRANSDERMAL PATCH
I WAS PRESCRIBED THE 50 MCG/HR FENTANYL PATCH FOR CHRONIC BACK PAIN & DEGENERATIVE DISC DISEASE. I WAS GIVEN THE PRE... 319 replies
fentanyl patch withdrawal symptoms and duration
i have post surgical lower back pain. was in 50 mcg patch and had side effects and so decided to wean off. i finished wi... 310 replies
FENTANYL PATCH
CAN ANYONE TELL ME HOW TO KEEP THE PATCH FROM COMING OFF AFTER SECOND DAY ? I SHOWER A COUPLE TIMES A DAY AND ON THE SEC... 215 replies
Fentanyl Can I Just Go Cold Turkey When Quitting
My doctor has had me on the 100 fentanyl patch for 1 year now. He is going to take me off it. Can you just stop taking i... 145 replies
Fentanyl Patches Killing people!
I would like to know WHY the FDA has not taken the Fentanyl Patch off the market? This drug is being handed out like can... 101 replies
Fentanyl Sweating
I am a 33 yr old woman being treated by Pain Mgmt Dr. for chronic pain as a result of 3 failed elbow surgeries and nerve... 69 replies
fentanyl patch wearing out
Hello. I am on the fentanyl patch, 125mcg every 72 hours. And ever since starting the patch I have been able to once aga... 49 replies




Notice: The MedsChat® NDC Database compiles publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.


Note: All times displayed are GMT - 7.

This information has been independently compiled and is for informational purposes only. It is not intended to be a substitute for medical advice from a qualified healthcare professional; nor is it intended to diagnose, treat, cure or prevent any disease. For more details please see the Medical Disclaimer. This page was last updated on 7 August 2015.

We are committed to your privacy.

Copyright © 2005-2020 All Rights Reserved. MedsChat® is a registered trademark of Limelight Innovations L.L.C. 9888 W Belleview Ave #5000, Denver, CO, 80123, USA