13551-002 : Lumryz 6 g/1 Oral for Suspension, Extended Release


NDC13551-002
Labeler: Avadel Cns Pharmaceuticals, LLC
Product Type: Human Prescription Drug
Drug Name:  Lumryz
Dosage Form: Oral for Suspension, Extended Release
Application #: NDA214755
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 13551-002-07: 7 PACKET IN 1 CARTON (13551‑002‑07) / 1 FOR SUSPENSION, EXTENDED RELEASE IN 1 PACKET (13551‑002‑00)
  • 13551-002-30: 30 PACKET IN 1 CARTON (13551‑002‑30) / 1 FOR SUSPENSION, EXTENDED RELEASE IN 1 PACKET (13551‑002‑00)

Active Ingredients:

  • Sodium Oxybate

Dosage Strength:

  • 6 g/1

Pharmaceutical Classes:

  • Central Nervous System Depressant [EPC]
  • Central Nervous System Depression [PE]
  • Decreased Central Nervous System Organized Electrical Activity [PE]

Related Products:

Based on records with the same trade name.
  • 13551-001 Lumryz 4.5 g/1 Oral for Suspension, Extended Release by Avadel Cns Pharmaceuticals, LLC
  • 13551-003 Lumryz 7.5 g/1 Oral for Suspension, Extended Release by Avadel Cns Pharmaceuticals, LLC
  • 13551-004 Lumryz 9 g/1 Oral for Suspension, Extended Release by Avadel Cns Pharmaceuticals, LLC

NDC QR Code

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

NDC 13551-002 QR Code

< Prev: 13551-001Next: 13551-003 >

Related Discussions:

what is sodium oxybate?
I am using it for a sleeping aid - however it is also known as the 'date rape drug' - let me tell you, I can und... 1 reply
Sodium Valproate and pregnancy
I have epilepsy and have taken Sodium Valproate 300 mg daily for nearly 5 years. I am now pregnant and want to know if t... 7 replies
Sodium level coming down
My mother is 79yrs old. She has had an Electrolyte problem for the last 2 yrs. Sodium levels are coming down. This is th... 4 replies
Sodium Hyaluronate or Hyaluronic Acid with Warfarin
Can Sodium Hyaluronate or Hyaluronic Acid be taken with Warfarin? ## Sorry, I am not finding any information on this. Ha... 2 replies
sodium lauryl sulfate and sodium laureth sulfate
how is this helpful in medicine - like bystolic 5mg for high blood pressure? I thought it was a foaming agent for deterg... 2 replies
Sodium Tetraborate Information and Safety
What are the dangers of Sodium Tetraborate? Is it harmful if swallowed by a toddler of 11 months? Do I need to call pois... 1 reply
Sodium level stays at 135
My father's (58 yrs old) sodium level stays at 135 and he is taking natrise 15 mg on alternative days but still he s... 1 reply
Sodium Valproate Ingridients
i"m looking for the ingredients of sodium val as my nephew has angel man syndrome and has been diagnosed with epilep... 1 reply
sodium chloride pills
why are they hard on your stomach ## Sodium Chloride is basically just salt, and while all medications are hard on your ... 1 reply
SODIUM FLUORIDE GEL
A topical fluoride gel used to prevent tooth decay. ## Common brand name: PreviDent (Sodium Flouride Gel Prescription On... 1 reply




Note: The RxChat NDC Database uses 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.