RASAGILINE

Orange BookUNIISPLATC N04BD02

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

Identification

ManufacturerMicro Labs Limited

CountryUS (United States)

ATC codeN04BD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
4257122105
500 TABLET in 1 BOTTLE (42571-221-05)
ndc11
4257122110
1000 TABLET in 1 BOTTLE (42571-221-10)
ndc11
4257122130
30 TABLET in 1 BOTTLE (42571-221-30)

Annotations

UNII (FDA Substance ID)

LH8C2JI290

RASAGILINE MESYLATE

RxCUI 577300

Orange Book

A207004

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": "42571-221_362d24c1-c384-4543-e063-6294a90a6b8f",
  "productndc": "42571-221",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "207004",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "Mar 29, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "Mar 29, 2019"
      }
    ],
    "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": "ANDA207004",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Rasagiline",
  "start_marketing_date": "20190403",
  "active_numerator_strength": "1"
}

Related drugs

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