Relistor

Orange BookUNIISPLATC A06AH01

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

Identification

ManufacturerSalix Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeA06AH01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6564955204
7 BLISTER PACK in 1 CARTON (65649-552-04) / 1 SYRINGE in 1 BLISTER PACK / .4 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

RFO6IL3D3M

METHYLNALTREXONE BROMIDE

RxCUI 979111

Orange Book

N021964

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "RFO6IL3D3M",
    "rxcui": "979111",
    "inchikey": "IFGIYSGOEZJNBE-NQMNLMSRSA-N",
    "display_name": "METHYLNALTREXONE BROMIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "c488fb7c-0a5b-487c-b452-996809d1cb99": {
      "match": "brand_token",
      "title": "RELISTOR (METHYLNALTREXONE BROMIDE) TABLET RELISTOR (METHYLNALTREXONE BROMIDE) INJECTION, SOLUTION [SALIX PHARMACEUTICALS, INC.]",
      "spl_version": "68",
      "published_date": "2026-05-20"
    }
  },
  "productid": "65649-552_9db15b8c-2928-4b75-a33b-548416afc8c9",
  "productndc": "65649-552",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021964",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "12MG/0.6ML (12MG/0.6ML)",
        "product_no": "001",
        "approval_date": "Apr 24, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "8MG/0.4ML (8MG/0.4ML)",
        "product_no": "002",
        "approval_date": "Sep 27, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "12MG/0.6ML (12MG/0.6ML)",
        "product_no": "003",
        "approval_date": "Sep 27, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "METHYLNALTREXONE BROMIDE",
  "proprietary_name": "Relistor",
  "active_ingred_unit": "mg/.4mL",
  "application_number": "NDA021964",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methylnaltrexone bromide",
  "start_marketing_date": "20080424",
  "active_numerator_strength": "8"
}

Related drugs

Other records sharing ATC code A06AH01.

Access this data programmatically

Query Relistor and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs