THIAMINE HYDROCHLORIDE injection, solution

Orange BookUNIISPLATC A11DA01

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 codeA11DA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166216353
25 POUCH in 1 CASE (51662-1635-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1635-2) / 2 mL in 1 VIAL, MULTI-DOSE (51662-1635-1)

Annotations

UNII (FDA Substance ID)

M572600E5P

THIAMINE HYDROCHLORIDE

RxCUI 235355

Orange Book

A080571

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": "51662-1635_5140c112-45d0-6503-e063-6394a90af692",
  "productndc": "51662-1635",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "080571",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "200MG/ML",
        "product_no": "002",
        "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 injection, solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA080571",
  "marketing_category": "ANDA",
  "nonproprietary_name": "THIAMINE HYDROCHLORIDE injection, solution",
  "start_marketing_date": "20230926",
  "active_numerator_strength": "100"
}

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