thiamine hydrochloride

Orange BookUNIISPLATC A11DA01

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

Identification

ManufacturerSagent Pharmaceuticals

CountryUS (United States)

ATC codeA11DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
2502150002
25 VIAL in 1 CARTON (25021-500-02) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

M572600E5P

THIAMINE HYDROCHLORIDE

RxCUI 235355

Orange Book

A206106

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": "25021-500_644d12b5-9a05-47dc-9e1c-d8f6fe9bbec2",
  "productndc": "25021-500",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "206106",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Dec 1, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "THIAMINE HYDROCHLORIDE",
  "proprietary_name": "thiamine hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206106",
  "marketing_category": "ANDA",
  "nonproprietary_name": "thiamine hydrochloride",
  "start_marketing_date": "20210120",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code A11DA01.

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