lumryz

Generic: sodium oxybate

Labeler: avadel cns pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lumryz
Generic Name sodium oxybate
Labeler avadel cns pharmaceuticals, llc
Dosage Form FOR SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

sodium oxybate 9 g/1

Manufacturer
Avadel CNS Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 13551-004
Product ID 13551-004_bd9a6c48-be50-44e5-8cbb-87cbaafe936d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214755
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-05-01

Pharmacologic Class

Classes
central nervous system depressant [epc] central nervous system depression [pe] decreased central nervous system organized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13551004
Hyphenated Format 13551-004

Supplemental Identifiers

RxCUI
2636822 2636828 2636830 2636832 2636834 2636836 2636838 2636840 2698135 2698136
UNII
7G33012534

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name lumryz (source: ndc)
Generic Name sodium oxybate (source: ndc)
Application Number NDA214755 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 9 g/1
source: ndc
Packaging
  • 7 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
  • 30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
source: ndc

Packages (2)

13551-004-07 7 PACKET in 1 CARTON (13551-004-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET 13551-004-30 30 PACKET in 1 CARTON (13551-004-30) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET

Ingredients (1)

sodium oxybate (9 g/1)

Linked Drug Pages (1)

Lumryz ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bd9a6c48-be50-44e5-8cbb-87cbaafe936d", "openfda": {"unii": ["7G33012534"], "rxcui": ["2636822", "2636828", "2636830", "2636832", "2636834", "2636836", "2636838", "2636840", "2698135", "2698136"], "spl_set_id": ["10e5e40c-52f3-4c73-8a34-2c29c690a934"], "manufacturer_name": ["Avadel CNS Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 PACKET in 1 CARTON (13551-004-07)  / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET", "package_ndc": "13551-004-07", "marketing_start_date": "20230501"}, {"sample": false, "description": "30 PACKET in 1 CARTON (13551-004-30)  / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET", "package_ndc": "13551-004-30", "marketing_start_date": "20230501"}], "brand_name": "Lumryz", "product_id": "13551-004_bd9a6c48-be50-44e5-8cbb-87cbaafe936d", "dosage_form": "FOR SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Central Nervous System Depressant [EPC]", "Central Nervous System Depression [PE]", "Decreased Central Nervous System Organized Electrical Activity [PE]"], "product_ndc": "13551-004", "dea_schedule": "CIII", "generic_name": "sodium oxybate", "labeler_name": "Avadel CNS Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lumryz", "active_ingredients": [{"name": "SODIUM OXYBATE", "strength": "9 g/1"}], "application_number": "NDA214755", "marketing_category": "NDA", "marketing_start_date": "20230501", "listing_expiration_date": "20261231"}