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United States · US · US:70518-4362_37ed5715-4431-ba05-e063-6394a90a5e0a

Rizatriptan Benzoate

Orange BookUNIISPLATC N02CC04

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN02CC04
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051843620
    3 BLISTER PACK in 1 CARTON (70518-4362-0) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
WR978S7QHH
RIZATRIPTAN BENZOATE
RxCUI 237082
Orange Book
A203062
ABAB
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": {
    "f754388d-77f1-0d8d-e053-6394a90a7b7e": {
      "match": "brand_token",
      "title": "RIZATRIPTAN BENZOATE TABLET, FILM COATED [DIRECT_RX]",
      "spl_version": "4",
      "published_date": "2026-03-18"
    }
  },
  "productid": "70518-4362_37ed5715-4431-ba05-e063-6394a90a5e0a",
  "productndc": "70518-4362",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "203062",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 1, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Jul 1, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIZATRIPTAN BENZOATE",
  "proprietary_name": "Rizatriptan Benzoate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203062",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rizatriptan Benzoate",
  "start_marketing_date": "20250618",
  "active_numerator_strength": "10"
}

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