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United States · US · US:0093-3060_c26cc45d-41aa-456c-8b37-49420366d1f4

Rasagiline

Orange BookUNIISPLATC N04BD02

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.
CountryUS (United States)
ATC codeN04BD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0093306056
    30 TABLET in 1 BOTTLE (0093-3060-56)

Annotations

UNII (FDA Substance ID)
LH8C2JI290
RASAGILINE MESYLATE
RxCUI 577300
Orange Book
N021641
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "LH8C2JI290",
    "rxcui": "577300",
    "inchikey": "JDBJJCWRXSVHOQ-UTONKHPSSA-N",
    "display_name": "RASAGILINE MESYLATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2c5e3cde-1158-4b5a-9a2b-ea6c987a65e4": {
      "match": "brand_token",
      "title": "RASAGILINE TABLET [TORRENT PHARMACEUTICALS LIMITED]",
      "spl_version": "6",
      "published_date": "2026-05-13"
    }
  },
  "productid": "0093-3060_c26cc45d-41aa-456c-8b37-49420366d1f4",
  "productndc": "0093-3060",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "021641",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "May 16, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "May 16, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RASAGILINE MESYLATE",
  "proprietary_name": "Rasagiline",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021641",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Rasagiline",
  "start_marketing_date": "20170103",
  "active_numerator_strength": ".5"
}

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