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United States · US · US:81968-020_b625951b-f029-470d-8d35-f5b6a92a06bb

SYMBRAVO

Orange BookUNIISPLATC M01AC

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAxsome Therapeutics, Inc.
CountryUS (United States)
ATC codeM01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8196802002
    1 BOTTLE in 1 CARTON (81968-020-02) / 2 TABLET in 1 BOTTLE
  • ndc11
    8196802003
    1 BOTTLE in 1 CARTON (81968-020-03) / 3 TABLET in 1 BOTTLE
  • ndc11
    8196802009
    9 TABLET in 1 BOTTLE (81968-020-09)

Annotations

UNII (FDA Substance ID)
VG2QF83CGL
MELOXICAM
RxCUI 41493
Orange Book
N215431
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "VG2QF83CGL",
    "rxcui": "41493",
    "inchikey": "ZRVUJXDFFKFLMG-UHFFFAOYSA-N",
    "display_name": "MELOXICAM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dcf1ecd1-08a0-8e47-e053-2a95a90abdc7": {
      "match": "brand_token",
      "title": "SYMBRAVO (MELOXICAM, RIZATRIPTAN) TABLET [AXSOME THERAPEUTICS, INC.]",
      "spl_version": "5",
      "published_date": "2025-11-24"
    }
  },
  "productid": "81968-020_b625951b-f029-470d-8d35-f5b6a92a06bb",
  "productndc": "81968-020",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215431",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG;EQ 10MG BASE",
        "product_no": "001",
        "approval_date": "Jan 30, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "MELOXICAM; RIZATRIPTAN BENZOATE",
  "proprietary_name": "SYMBRAVO",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA215431",
  "marketing_category": "NDA",
  "nonproprietary_name": "meloxicam, rizatriptan",
  "start_marketing_date": "20250519",
  "active_numerator_strength": "20; 10"
}

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