Acetylcysteine

Orange BookUNIISPLATC R05CB01

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

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC codeR05CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0517760425
25 VIAL, GLASS in 1 TRAY (0517-7604-25) / 4 mL in 1 VIAL, GLASS

Annotations

UNII (FDA Substance ID)

WYQ7N0BPYC

ACETYLCYSTEINE

RxCUI 197

Orange Book

A072547

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": "0517-7604_2bcb9dd3-17f8-439e-a395-aa081c5cc4bf",
  "productndc": "0517-7604",
  "dosage_form": "INHALANT",
  "orange_book": {
    "appl_no": "072547",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AN",
        "strength": "20%",
        "product_no": "001",
        "approval_date": "Jul 28, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETYLCYSTEINE",
  "proprietary_name": "Acetylcysteine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA072547",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetylcysteine",
  "start_marketing_date": "19951001",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code R05CB01.

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