rizatriptan benzoate

Orange BookUNIISPLATC N02CC04

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

Identification

ManufacturerMacleods Pharmaceuticals Limited

CountryUS (United States)

ATC codeN02CC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 11

ndc11
3334209404
12 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-04)
ndc11
3334209407
30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-07)
ndc11
3334209412
10 BLISTER PACK in 1 CARTON (33342-094-12) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ndc11
3334209423
18 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-23)
ndc11
3334209441
3 BLISTER PACK in 1 CARTON (33342-094-41) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ndc11
3334209445
2 BLISTER PACK in 1 CARTON (33342-094-45) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ndc11
3334209446
200 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-094-46)
ndc11
3334209447
4 POUCH in 1 CARTON (33342-094-47) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ndc11
3334209452
1 BLISTER PACK in 1 CARTON (33342-094-52) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ndc11
3334209472
6 BLISTER PACK in 1 CARTON (33342-094-72) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ndc11
3334209473
3 BLISTER PACK in 1 CARTON (33342-094-73) / 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

WR978S7QHH

RIZATRIPTAN BENZOATE

RxCUI 237082

Orange Book

A203146

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": "33342-094_137f6265-8c70-4748-a0d5-3976274e4ea0",
  "productndc": "33342-094",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "203146",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 19, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Sep 19, 2014"
      }
    ],
    "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": "ANDA203146",
  "marketing_category": "ANDA",
  "nonproprietary_name": "rizatriptan benzoate",
  "start_marketing_date": "20140923",
  "active_numerator_strength": "10"
}

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