SODIUM TETRADECYL SULFATE

Orange BookUNIISPL

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

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166215621
2 mL in 1 VIAL, MULTI-DOSE (51662-1562-1)

Annotations

UNII (FDA Substance ID)

6326W0DRHY

TETRADECYL HYDROGEN SULFATE (ESTER)

RxCUI 1370424

Orange Book

A040541

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6326W0DRHY",
    "rxcui": "1370424",
    "inchikey": "GROJOWHVXQYQGN-UHFFFAOYSA-N",
    "display_name": "TETRADECYL HYDROGEN SULFATE (ESTER)",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "52430b12-4d5f-d1e1-e063-6394a90abd64": {
      "match": "brand_token",
      "title": "SODIUM FLUORIDE RINSE LIQUID [ROCKLAND COSMETICS, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-21"
    }
  },
  "productid": "51662-1562_1203bbfe-c55f-1bcb-e063-6394a90a6577",
  "productndc": "51662-1562",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "040541",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "20MG/2ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 12, 2004"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "60MG/2ML (30MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 12, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TETRADECYL HYDROGEN SULFATE (ESTER)",
  "proprietary_name": "SODIUM TETRADECYL SULFATE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA040541",
  "marketing_category": "ANDA",
  "nonproprietary_name": "SODIUM TETRADECYL SULFATE",
  "start_marketing_date": "20210718",
  "active_numerator_strength": "10"
}

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