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United States · US · US:65145-129_66c1e502-6c85-43a5-b9a7-76368ebd39bc

Thiamine

Orange BookUNIISPLATC A11DA01

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

Identification

ManufacturerCaplin Steriles Limited
CountryUS (United States)
ATC codeA11DA01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6514512925
    25 VIAL, MULTI-DOSE in 1 CARTON (65145-129-25) / 2 mL in 1 VIAL, MULTI-DOSE (65145-129-01)

Annotations

UNII (FDA Substance ID)
M572600E5P
THIAMINE HYDROCHLORIDE
RxCUI 235355
Orange Book
A215692
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": "65145-129_66c1e502-6c85-43a5-b9a7-76368ebd39bc",
  "productndc": "65145-129",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "215692",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Mar 6, 2023"
      }
    ],
    "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": "ANDA215692",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Thiamine Hydrochloride",
  "start_marketing_date": "20240520",
  "active_numerator_strength": "100"
}

Related drugs

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