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United States · US · US:0006-5423_26634a32-bcb0-478d-a176-1bf6c6d6f1b3

BRIDION

Orange BookUNIISPLATC V03AB35

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMerck Sharp & Dohme LLC
CountryUS (United States)
ATC codeV03AB35
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0006542312
    10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-12) / 2 mL in 1 VIAL, SINGLE-DOSE (0006-5423-02)
  • ndc11
    0006542315
    10 VIAL, SINGLE-DOSE in 1 CARTON (0006-5423-15) / 5 mL in 1 VIAL, SINGLE-DOSE (0006-5423-05)

Annotations

UNII (FDA Substance ID)
ERJ6X2MXV7
SUGAMMADEX SODIUM
RxCUI 1726987
Orange Book
N022225
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "ERJ6X2MXV7",
    "rxcui": "1726987",
    "inchikey": "KMGKABOMYQLLDJ-VKHHSAQNSA-F",
    "display_name": "SUGAMMADEX SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "5171d883-fe8f-482c-97ab-40b00975b64a": {
      "match": "brand_token",
      "title": "BRIDION (SUGAMMADEX) INJECTION, SOLUTION [MERCK SHARP & DOHME LLC]",
      "spl_version": "26",
      "published_date": "2026-04-02"
    }
  },
  "productid": "0006-5423_26634a32-bcb0-478d-a176-1bf6c6d6f1b3",
  "productndc": "0006-5423",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022225",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 500MG BASE/5ML (EQ 100MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 15, 2015"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 200MG BASE/2ML (EQ 100MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Dec 15, 2015"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "SUGAMMADEX SODIUM",
  "proprietary_name": "BRIDION",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022225",
  "marketing_category": "NDA",
  "nonproprietary_name": "sugammadex",
  "start_marketing_date": "20151215",
  "active_numerator_strength": "100"
}

Related drugs

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