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 · 3

ndc11
6564955102
1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE
ndc11
6564955103
7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
ndc11
6564955107
1 BLISTER PACK in 1 CARTON (65649-551-07) / 1 SYRINGE in 1 BLISTER PACK / .6 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": "65649-551_9db15b8c-2928-4b75-a33b-548416afc8c9",
  "productndc": "65649-551",
  "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/.6mL",
  "application_number": "NDA021964",
  "marketing_category": "NDA",
  "nonproprietary_name": "Methylnaltrexone bromide",
  "start_marketing_date": "20080424",
  "active_numerator_strength": "12"
}

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