RASAGILINE

Orange BookUNIISPLATC N04BD02

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

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeN04BD02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
1366844705
500 TABLET in 1 CONTAINER (13668-447-05)
ndc11
1366844730
30 TABLET in 1 CONTAINER (13668-447-30)
ndc11
1366844790
90 TABLET in 1 CONTAINER (13668-447-90)

Annotations

UNII (FDA Substance ID)

LH8C2JI290

RASAGILINE MESYLATE

RxCUI 577300

Orange Book

A210150

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": "13668-447_fa1b2a7e-f459-4432-97f2-23d2c07c2dac",
  "productndc": "13668-447",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "210150",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 0.5MG BASE",
        "product_no": "001",
        "approval_date": "May 5, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "002",
        "approval_date": "May 5, 2025"
      }
    ],
    "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": "ANDA210150",
  "marketing_category": "ANDA",
  "nonproprietary_name": "RASAGILINE",
  "start_marketing_date": "20251115",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code N04BD02.

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