Rasagiline

Orange BookUNIISPLATC N04BD02

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

Identification

ManufacturerAlvogen, Inc.

CountryUS (United States)

ATC codeN04BD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4778168330
30 TABLET in 1 BOTTLE, PLASTIC (47781-683-30)

Annotations

UNII (FDA Substance ID)

LH8C2JI290

RASAGILINE MESYLATE

RxCUI 577300

Orange Book

A201970

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": "47781-683_9726c72c-4d6a-6707-a9bf-e3716476f816",
  "productndc": "47781-683",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "201970",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 15, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Mar 15, 2016"
      }
    ],
    "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": "ANDA201970",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rasagiline",
  "start_marketing_date": "20190301",
  "active_numerator_strength": ".5"
}

Related drugs

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