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United States · US · US:67877-260_f8b285b7-ed55-4260-bbc7-ebfdff15f6c9

Rasagiline

Orange BookUNIISPLATC N04BD02

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

Identification

ManufacturerAscend Laboratories, LLC
CountryUS (United States)
ATC codeN04BD02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6787726030
    30 TABLET in 1 BOTTLE (67877-260-30)

Annotations

UNII (FDA Substance ID)
LH8C2JI290
RASAGILINE MESYLATE
RxCUI 577300
Orange Book
A201889
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": "67877-260_f8b285b7-ed55-4260-bbc7-ebfdff15f6c9",
  "productndc": "67877-260",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201889",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Oct 30, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Oct 30, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RASAGILINE MESYLATE",
  "proprietary_name": "Rasagiline",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA201889",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rasagiline",
  "start_marketing_date": "20171030",
  "active_numerator_strength": "1"
}

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