Acetylcysteine

Orange BookUNIISPLATC R05CB01

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

Identification

ManufacturerHospira, Inc.

CountryUS (United States)

ATC codeR05CB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0409330703
3 VIAL in 1 CARTON (0409-3307-03) / 30 mL in 1 VIAL (0409-3307-11)

Annotations

UNII (FDA Substance ID)

WYQ7N0BPYC

ACETYLCYSTEINE

RxCUI 197

Orange Book

A073664

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": "0409-3307_6c12470d-0f1a-4085-938d-121df34c3cb0",
  "productndc": "0409-3307",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "073664",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AN",
        "strength": "10%",
        "product_no": "001",
        "approval_date": "Aug 30, 1994"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ACETYLCYSTEINE",
  "proprietary_name": "Acetylcysteine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA073664",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ACETYLCYSTEINE",
  "start_marketing_date": "20050430",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code R05CB01.

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