Acetylcysteine

Orange BookUNIISPLATC R05CB01

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeR05CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332369404
25 VIAL in 1 CARTON (63323-694-04) / 4 mL in 1 VIAL (63323-694-22)

Annotations

UNII (FDA Substance ID)

WYQ7N0BPYC

ACETYLCYSTEINE

RxCUI 197

Orange Book

A203853

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": "ORAL; RESPIRATORY (INHALATION)",
  "spl_meta": {
    "5558a5f5-e821-473b-7d8a-5d33d09f0586": {
      "match": "brand_token",
      "title": "ACETYLCYSTEINE SOLUTION [HOSPIRA, INC.]",
      "spl_version": "22",
      "published_date": "2026-05-25"
    }
  },
  "productid": "63323-694_da00a3b4-d7e8-464b-a13f-422b445de8ee",
  "productndc": "63323-694",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "203853",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "20%",
        "product_no": "001",
        "approval_date": "Jun 21, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETYLCYSTEINE",
  "proprietary_name": "Acetylcysteine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203853",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ACETYLCYSTEINE",
  "start_marketing_date": "20120901",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code R05CB01.

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