Acetylcysteine

Orange BookUNIISPLATC R05CB01

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

Identification

ManufacturerSomerset Therapeutics, LLC

CountryUS (United States)

ATC codeR05CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7006901925
25 VIAL in 1 CARTON (70069-019-25) / 4 mL in 1 VIAL (70069-019-01)

Annotations

UNII (FDA Substance ID)

WYQ7N0BPYC

ACETYLCYSTEINE

RxCUI 197

Orange Book

A219194

ANAN

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": "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": "70069-019_af1a403e-02e4-4d18-bb00-6629a8e7c261",
  "productndc": "70069-019",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "219194",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Feb 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "20%",
        "product_no": "002",
        "approval_date": "Feb 12, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETYLCYSTEINE",
  "proprietary_name": "Acetylcysteine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA219194",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetylcysteine",
  "start_marketing_date": "20250304",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code R05CB01.

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