Thiamine

Orange BookUNIISPLATC A11DA01

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeA11DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332301309
25 VIAL, MULTI-DOSE in 1 TRAY (63323-013-09) / 2 mL in 1 VIAL, MULTI-DOSE (63323-013-21)

Annotations

UNII (FDA Substance ID)

M572600E5P

THIAMINE HYDROCHLORIDE

RxCUI 235355

Orange Book

A080556

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "M572600E5P",
    "rxcui": "235355",
    "inchikey": "DPJRMOMPQZCRJU-UHFFFAOYSA-M",
    "display_name": "THIAMINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "2e957a35-83b3-47f5-ad09-216b22cc30be": {
      "match": "brand_token",
      "title": "THIAMINE HYDROCHLORIDE INJECTION, SOLUTION [ONESOURCE SPECIALTY PHARMA LIMITED]",
      "spl_version": "3",
      "published_date": "2026-05-25"
    }
  },
  "productid": "63323-013_3b09217b-e746-4523-95fa-b78fad431e32",
  "productndc": "63323-013",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "080556",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THIAMINE HYDROCHLORIDE",
  "proprietary_name": "Thiamine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA080556",
  "marketing_category": "ANDA",
  "nonproprietary_name": "THIAMINE HYDROCHLORIDE",
  "start_marketing_date": "20000901",
  "active_numerator_strength": "100"
}

Related drugs

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