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 KIT
Manufacturer
Avadel CNS Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 13551-005
Product ID 13551-005_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 2024-10-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13551005
Hyphenated Format 13551-005

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: label

Resolved Composition

Strengths
  • 4.5 g
  • 6 g
  • 7.5 g
  • 9 g
source: label
Packaging
  • 1 KIT in 1 CARTON (13551-005-01) * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET
source: ndc

Packages (1)

13551-005-01 1 KIT in 1 CARTON (13551-005-01) * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET * 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Lumryz ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"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": "1 KIT in 1 CARTON (13551-005-01)  *  1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET *  1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET *  1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET", "package_ndc": "13551-005-01", "marketing_start_date": "20241007"}], "brand_name": "Lumryz", "product_id": "13551-005_bd9a6c48-be50-44e5-8cbb-87cbaafe936d", "dosage_form": "KIT", "product_ndc": "13551-005", "dea_schedule": "CIII", "generic_name": "sodium oxybate", "labeler_name": "Avadel CNS Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lumryz", "application_number": "NDA214755", "marketing_category": "NDA", "marketing_start_date": "20241007", "listing_expiration_date": "20261231"}