Azilect

Orange BookUNIISPLATC N04BD02

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

Identification

ManufacturerTeva Neuroscience, Inc.

CountryUS (United States)

ATC codeN04BD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6854622956
30 TABLET in 1 BOTTLE (68546-229-56)

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": {
    "a40d0e73-3f9f-4b01-979d-402c9cdaeb60": {
      "match": "brand_token",
      "title": "AZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]",
      "spl_version": "25",
      "published_date": "2025-08-28"
    }
  },
  "productid": "68546-229_e90d2f30-97b1-4c76-8038-df259889e3b5",
  "productndc": "68546-229",
  "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": "Azilect",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021641",
  "marketing_category": "NDA",
  "nonproprietary_name": "Rasagiline mesylate",
  "start_marketing_date": "20060710",
  "active_numerator_strength": "1"
}

Related drugs

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