acetylcysteine

Orange BookUNIISPLATC R05CB01

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

Identification

ManufacturerPadagis US LLC

CountryUS (United States)

ATC codeR05CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0574080530
4 VIAL in 1 CARTON (0574-0805-30) / 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": {
    "5558a5f5-e821-473b-7d8a-5d33d09f0586": {
      "match": "brand_token",
      "title": "ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]",
      "spl_version": "22",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0574-0805_b123834f-a908-4e77-bf87-32dffefa20f1",
  "productndc": "0574-0805",
  "dosage_form": "INJECTION",
  "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": "acetylcysteine",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021539",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Acetylcysteine",
  "start_marketing_date": "20121220",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code R05CB01.

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