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NDC 13551-0001-07 Lumryz 4.5 g/1 Details
Lumryz 4.5 g/1
Lumryz is a ORAL FOR SUSPENSION, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Avadel CNS Pharmaceuticals, LLC. The primary component is SODIUM OXYBATE.
Product Information
| NDC | 13551-0001 |
|---|---|
| Product ID | 13551-001_60d0294f-268e-49a7-9303-71469c4295cc |
| Associated GPIs | |
| GCN Sequence Number | 084718 |
| GCN Sequence Number Description | sodium oxybate PACK ER GR 4.5 G ORAL |
| HIC3 | H7W |
| HIC3 Description | ANTI-NARCOLEPSY,ANTI-CATAPLEXY,SEDATIVE-TYPE AGENT |
| GCN | 54076 |
| HICL Sequence Number | 012346 |
| HICL Sequence Number Description | SODIUM OXYBATE |
| Brand/Generic | Brand |
| Proprietary Name | Lumryz |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | sodium oxybate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | FOR SUSPENSION, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 4.5 |
| Active Ingredient Units | g/1 |
| Substance Name | SODIUM OXYBATE |
| Labeler Name | Avadel CNS Pharmaceuticals, LLC |
| Pharmaceutical Class | Central Nervous System Depressant [EPC], Central Nervous System Depression [PE], Decreased Central Nervous System Organized Electrical Activity [PE] |
| DEA Schedule | CIII |
| Marketing Category | NDA |
| Application Number | NDA214755 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 13551-0001-07 (13551000107)
| NDC Package Code | 13551-001-07 |
|---|---|
| Billing NDC | 13551000107 |
| Package | 7 PACKET in 1 CARTON (13551-001-07) / 1 FOR SUSPENSION, EXTENDED RELEASE in 1 PACKET |
| Marketing Start Date | 2023-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |