auvelity

Generic: dextromethorphan hydrobromide, bupropion hydrochloride

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

Drug Facts

Product Profile

Brand Name auvelity
Generic Name dextromethorphan hydrobromide, bupropion hydrochloride
Labeler axsome therapeutics, inc.
Dosage Form TABLET, MULTILAYER, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

bupropion hydrochloride 105 mg/1, dextromethorphan hydrobromide 45 mg/1

Manufacturer
Axsome Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 81968-045
Product ID 81968-045_02ca1e62-a4d4-4dc7-b2e8-908f926af1f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215430
Listing Expiration 2026-12-31
Marketing Start 2022-08-18

Pharmacologic Class

Classes
aminoketone [epc] dopamine uptake inhibitors [moa] increased dopamine activity [pe] increased norepinephrine activity [pe] norepinephrine uptake inhibitors [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81968045
Hyphenated Format 81968-045

Supplemental Identifiers

RxCUI
2611260 2611266
UPC
0381968045303 0381968045600 0381968045310 0381968045143
UNII
ZG7E5POY8O 9D2RTI9KYH

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 auvelity (source: ndc)
Generic Name dextromethorphan hydrobromide, bupropion hydrochloride (source: ndc)
Application Number NDA215430 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 105 mg/1
  • 45 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
  • 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30)
  • 1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
  • 60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60)
source: ndc

Packages (4)

81968-045-14 1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE 81968-045-30 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30) 81968-045-31 1 BOTTLE in 1 CARTON (81968-045-31) / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE 81968-045-60 60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60)

Ingredients (2)

bupropion hydrochloride (105 mg/1) dextromethorphan hydrobromide (45 mg/1)

Linked Drug Pages (1)

AUVELITY ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "02ca1e62-a4d4-4dc7-b2e8-908f926af1f2", "openfda": {"upc": ["0381968045303", "0381968045600", "0381968045310", "0381968045143"], "unii": ["ZG7E5POY8O", "9D2RTI9KYH"], "rxcui": ["2611260", "2611266"], "spl_set_id": ["dcefda7c-9a68-278e-e053-2995a90aec79"], "manufacturer_name": ["Axsome Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BOTTLE in 1 CARTON (81968-045-14)  / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "81968-045-14", "marketing_start_date": "20240918"}, {"sample": false, "description": "30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30)", "package_ndc": "81968-045-30", "marketing_start_date": "20220818"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (81968-045-31)  / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE", "package_ndc": "81968-045-31", "marketing_start_date": "20240510"}, {"sample": false, "description": "60 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-60)", "package_ndc": "81968-045-60", "marketing_start_date": "20240628"}], "brand_name": "AUVELITY", "product_id": "81968-045_02ca1e62-a4d4-4dc7-b2e8-908f926af1f2", "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE", "pharm_class": ["Aminoketone [EPC]", "Dopamine Uptake Inhibitors [MoA]", "Increased Dopamine Activity [PE]", "Increased Norepinephrine Activity [PE]", "Norepinephrine Uptake Inhibitors [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "81968-045", "generic_name": "dextromethorphan hydrobromide, bupropion hydrochloride", "labeler_name": "Axsome Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AUVELITY", "active_ingredients": [{"name": "BUPROPION HYDROCHLORIDE", "strength": "105 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "45 mg/1"}], "application_number": "NDA215430", "marketing_category": "NDA", "marketing_start_date": "20220818", "listing_expiration_date": "20261231"}