ACETADOTE

Orange BookUNIISPLATC R05CB01

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

Identification

ManufacturerCumberland Pharmaceuticals Inc.

CountryUS (United States)

ATC codeR05CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6622020730
4 VIAL in 1 CARTON (66220-207-30) / 30 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

WYQ7N0BPYC

ACETYLCYSTEINE

RxCUI 197

Orange Book

N021539

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WYQ7N0BPYC",
    "rxcui": "197",
    "inchikey": "PWKSKIMOESPYIA-BYPYZUCNSA-N",
    "display_name": "ACETYLCYSTEINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "472f158a-5ab9-4308-8e49-1116e6ea3d39": {
      "match": "brand_token",
      "title": "ACETADOTE (ACETYLCYSTEINE) INJECTION, SOLUTION [CUMBERLAND PHARMACEUTICALS INC.]",
      "spl_version": "17",
      "published_date": "2025-07-30"
    }
  },
  "productid": "66220-207_f8e9f360-c181-40a1-87d6-dcd9a3205000",
  "productndc": "66220-207",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021539",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "6GM/30ML (200MG/ML)",
        "product_no": "001",
        "approval_date": "Jan 23, 2004"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETYLCYSTEINE",
  "proprietary_name": "ACETADOTE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021539",
  "marketing_category": "NDA",
  "nonproprietary_name": "Acetylcysteine",
  "start_marketing_date": "20040123",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code R05CB01.

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