Quick answers
- What is Thiamine hydrochloride used for?
- The FDA-approved label (Thiamine Hydrochloride, Remedyrepack Inc., August 31, 2026) says: “INDICATIONS Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Thiamine hydrochloride have a boxed warning?
- No. None of the 21 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Thiamine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Thiamine hydrochloride been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started May 3, 2021 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Thiamine hydrochloride?
- 20 companies list prescription products of Thiamine hydrochloride in the FDA NDC Directory, including Fresenius Kabi USA, LLC, HF Acquisition Co LLC, DBA HealthFirst and Henry Schein, Inc..
What Thiamine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. …
— FDA label: Thiamine Hydrochloride, Remedyrepack Inc., effective August 31, 2026. Read the full label on DailyMed →
The FDA has 21 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 21 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 22 in the FDA NDC Directory |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| thiamine hydrochloride 100 mg/mL injection, solution | Generic | $2.13 per mL |
| thiamine hydrochloride 200 mg/2 mL injection, solution | Generic | $2.13 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fresenius Kabi USA, LLC3 products
- HF Acquisition Co LLC, DBA HealthFirst2 products
- Henry Schein, Inc.2 products
- Hikma Pharmaceuticals USA Inc.1 product
- Caplin Steriles Limited1 product
- Fosun Pharma USA Inc.1 product
- NorthStar RxLLC1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Remedyrepack Inc.1 product
- Camber Pharmaceuticals, Inc.1 product
- Gland Pharma Limited1 product
- Onesource Specialty Pharma Limited1 product
- Sagent Pharmaceuticals1 product
- Dr. Reddy's Laboratories Inc.1 product
- Meitheal Pharmaceuticals Inc.1 product
- Armas Pharmaceuticals Inc.1 product
- Mylan Institutional LLC1 product
- Eugia US LLC1 product
- NorthStar Rx LLC1 product
- Lifestar Pharma LLC1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (12)
- ANDA080556Fresenius Kabi USA · June 20, 1972
- ANDA080571DR Reddys · February 26, 1974
- ANDA080575West-Ward Pharms Int · June 24, 1975
- ANDA091623Mylan Institutional · June 25, 2012
- ANDA206106Sagent Pharms Inc · December 1, 2017
- ANDA208703Eugia Pharma · April 20, 2022
- ANDA215692Caplin · March 6, 2023
- ANDA217181Onesource Specialty · October 29, 2024
- ANDA218471Aspiro · November 6, 2024
- ANDA217800Gland · February 24, 2025
- ANDA220513Mankind Pharma · July 31, 2026
- ANDA213131Meitheal · September 25, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 3, 2021 · Class III · Terminated · D-0601-2021
Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactured by: Mylan Institu — Mylan Institutional LLC
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 313324 |
|---|---|
| SPL set ID of the quoted label | 0f38c4ba-cebf-49f4-b0a6-8a5d3ebf618c |
| FDA labels (SPL) | 21 |
| FDA applications | 12 ANDA |
| Active ingredients (FDA) | THIAMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Thiamine Hydrochloride, Remedyrepack Inc., effective August 31, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →