sunosi

Generic: solriamfetol

Labeler: axsome therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sunosi
Generic Name solriamfetol
Labeler axsome therapeutics, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

solriamfetol 75 mg/1

Manufacturer
Axsome Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 81968-350
Product ID 81968-350_4cb3c497-6479-4e6f-8767-50e8f7836e07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211230
DEA Schedule civ
Listing Expiration 2027-12-31
Marketing Start 2019-06-18

Pharmacologic Class

Established (EPC)
dopamine and norepinephrine reuptake inhibitor [epc]
Mechanism of Action
dopamine uptake inhibitors [moa] norepinephrine uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81968350
Hyphenated Format 81968-350

Supplemental Identifiers

RxCUI
2121756 2121758 2121764 2173841
UPC
0381968351015 0381968350018
UNII
939U7C91AI
NUI
N0000194049 N0000000114 N0000000102

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 sunosi (source: ndc)
Generic Name solriamfetol (source: ndc)
Application Number NDA211230 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01)
  • 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)
  • 10 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)
source: ndc

Packages (3)

81968-350-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01) 81968-350-07 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) 81968-350-10 10 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)

Ingredients (1)

solriamfetol (75 mg/1)

Linked Drug Pages (1)

SUNOSI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4cb3c497-6479-4e6f-8767-50e8f7836e07", "openfda": {"nui": ["N0000194049", "N0000000114", "N0000000102"], "upc": ["0381968351015", "0381968350018"], "unii": ["939U7C91AI"], "rxcui": ["2121756", "2121758", "2121764", "2173841"], "spl_set_id": ["362f206b-73e7-4009-8c34-5a9df55679ab"], "pharm_class_epc": ["Dopamine and Norepinephrine Reuptake Inhibitor [EPC]"], "pharm_class_moa": ["Dopamine Uptake Inhibitors [MoA]", "Norepinephrine Uptake Inhibitors [MoA]"], "manufacturer_name": ["Axsome Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01)", "package_ndc": "81968-350-01", "marketing_start_date": "20220602"}, {"sample": true, "description": "7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)", "package_ndc": "81968-350-07", "marketing_start_date": "20220602"}, {"sample": true, "description": "10 BLISTER PACK in 1 CARTON (81968-350-10)  / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)", "package_ndc": "81968-350-10", "marketing_start_date": "20220602"}], "brand_name": "SUNOSI", "product_id": "81968-350_4cb3c497-6479-4e6f-8767-50e8f7836e07", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Dopamine Uptake Inhibitors [MoA]", "Dopamine and Norepinephrine Reuptake Inhibitor [EPC]", "Norepinephrine Uptake Inhibitors [MoA]"], "product_ndc": "81968-350", "dea_schedule": "CIV", "generic_name": "solriamfetol", "labeler_name": "Axsome Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUNOSI", "active_ingredients": [{"name": "SOLRIAMFETOL", "strength": "75 mg/1"}], "application_number": "NDA211230", "marketing_category": "NDA", "marketing_start_date": "20190618", "listing_expiration_date": "20271231"}