CYSTEINE HYDROCHLORIDE

Orange BookUNIISPL

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338964501
5 VIAL, SINGLE-DOSE in 1 CARTON (0338-9645-01) / 10 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

ZT934N0X4W

CYSTEINE HYDROCHLORIDE

RxCUI 221086

Orange Book

N212535

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "ZT934N0X4W",
    "rxcui": "221086",
    "inchikey": "QIJRTFXNRTXDIP-JIZZDEOASA-N",
    "display_name": "CYSTEINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "cbf70fc3-14b3-4c17-8de8-acba1e12ac95": {
      "match": "brand_token",
      "title": "CYSTEINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]",
      "spl_version": "5",
      "published_date": "2026-02-19"
    }
  },
  "productid": "0338-9645_26874b67-a94f-46fd-82de-0b44b93d3db4",
  "productndc": "0338-9645",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "212535",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "500MG/10ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Dec 13, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYSTEINE HYDROCHLORIDE",
  "proprietary_name": "CYSTEINE HYDROCHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA212535",
  "marketing_category": "NDA",
  "nonproprietary_name": "cysteine hydrochloride",
  "start_marketing_date": "20220429",
  "active_numerator_strength": "34.5"
}

Access this data programmatically

Query CYSTEINE HYDROCHLORIDE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs