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United States · US · US:70518-4230_4005d19e-7cd8-f2db-e063-6394a90a9e7e

Thiamine Hydrochloride

Orange BookUNIISPLATC A11DA01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeA11DA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051842300
    25 VIAL in 1 CARTON (70518-4230-0) / 2 mL in 1 VIAL (70518-4230-1)

Annotations

UNII (FDA Substance ID)
M572600E5P
THIAMINE HYDROCHLORIDE
RxCUI 235355
Orange Book
A080575
AP
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": "70518-4230_4005d19e-7cd8-f2db-e063-6394a90a9e7e",
  "productndc": "70518-4230",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "080575",
    "products": [
      {
        "rs": false,
        "rld": false,
        "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 Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA080575",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Thiamine Hydrochloride",
  "start_marketing_date": "20241113",
  "active_numerator_strength": "100"
}

Related drugs

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