AUVELITY

Orange BookUNIISPLATC N06AX

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAxsome Therapeutics, Inc.

CountryUS (United States)

ATC codeN06AX

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8196803022
1 BOTTLE in 1 CARTON (81968-030-22) / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

ZG7E5POY8O

BUPROPION HYDROCHLORIDE

RxCUI 203204

Orange Book

N215430

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "ZG7E5POY8O",
    "rxcui": "203204",
    "inchikey": "HEYVINCGKDONRU-UHFFFAOYSA-N",
    "display_name": "BUPROPION HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dcefda7c-9a68-278e-e053-2995a90aec79": {
      "match": "brand_token",
      "title": "AUVELITY (DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [AXSOME THERAPEUTICS, INC.]",
      "spl_version": "14",
      "published_date": "2026-05-11"
    }
  },
  "productid": "81968-030_75c80bbe-3518-435c-8a6e-121fdc8a9982",
  "productndc": "81968-030",
  "dosage_form": "TABLET, MULTILAYER, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "215430",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "105MG;45MG",
        "product_no": "001",
        "approval_date": "Aug 18, 2022"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "105MG;30MG",
        "product_no": "002",
        "approval_date": "Apr 30, 2026"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE",
  "proprietary_name": "AUVELITY",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA215430",
  "marketing_category": "NDA",
  "nonproprietary_name": "dextromethorphan hydrobromide, bupropion hydrochloride",
  "start_marketing_date": "20260508",
  "active_numerator_strength": "105; 30"
}

Related drugs

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