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

NDC:	13551-002
Labeler:	Avadel Cns Pharmaceuticals, LLC
Product Type:	Human Prescription Drug
Drug Name:	Lumryz
Dosage Form:	Oral for Suspension, Extended Release
Application #:	NDA214755
Rev. Date:	May 1, 2023
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

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

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