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United States · US · US:78206-142_47257235-a46d-4fee-a29d-08f8ba8e46c2

MAXALT

Orange BookUNIISPLATC N02CC04

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

Identification

ManufacturerOrganon LLC
CountryUS (United States)
ATC codeN02CC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7820614201
    18 POUCH in 1 CARTON (78206-142-01) / 1 TABLET in 1 POUCH (78206-142-99)

Annotations

UNII (FDA Substance ID)
WR978S7QHH
RIZATRIPTAN BENZOATE
RxCUI 237082
Orange Book
N020864
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WR978S7QHH",
    "rxcui": "237082",
    "inchikey": "JPRXYLQNJJVCMZ-UHFFFAOYSA-N",
    "display_name": "RIZATRIPTAN BENZOATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "007b4644-e0e7-4863-9ae3-fe09676b3f5f": {
      "match": "brand_token",
      "title": "MAXALT (RIZATRIPTAN BENZOATE) TABLET MAXALT-MLT (RIZATRIPTAN BENZOATE) TABLET, ORALLY DISINTEGRATING [ORGANON LLC]",
      "spl_version": "4",
      "published_date": "2026-02-06"
    }
  },
  "productid": "78206-142_47257235-a46d-4fee-a29d-08f8ba8e46c2",
  "productndc": "78206-142",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "020864",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Jun 29, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Jun 29, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIZATRIPTAN BENZOATE",
  "proprietary_name": "MAXALT",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020864",
  "marketing_category": "NDA",
  "nonproprietary_name": "rizatriptan benzoate",
  "start_marketing_date": "20210601",
  "active_numerator_strength": "10"
}

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