Registrants2
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
599466600
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
ONESOURCE SPECIALTY PHARMA LIMITED
Onesource Specialty Pte. Limited
867530307
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Thiamine Hydrochloride
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 83270-004-01** Rx only**
**Thiamine Hydrochloride**
Injection, USP
200 mg per 2 mL
(100 mg per mL)
For Intramuscular or Intravenous use.
Protect from light.
NDC 83270-004-03Rx only
Thiamine Hydrochloride
Injection, USP
200 mg per 2 mL (100 mg per mL)
For Intramuscular or Intravenous use.
25 x 2 mL Multiple-Dose Vials
DESCRIPTION SECTION
DESCRIPTION
Thiamine Hydrochloride Injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration.
Each mL contains: Thiamine hydrochloride 100 mg; chlorobutanol anhydrous (chloral derivative) 0.5%; monothioglycerol 0.5%; water for injection, q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5).
Thiamine hydrochloride, or vitamin B 1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution.
The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5 pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula:
C12H17ClN4OS . HCl M.W. 337.27