FDA-filed SPL labeling · retrieved through openFDA

Pyridoxine

Pyridoxine (vitamin B6) is a B vitamin given by injection to treat pyridoxine deficiency caused by poor diet, certain medications, or inherited metabolic disorders.

Brand names Hexa-betalinPyridoxine Hci
Drug classes Analogs/derivatives
Rx Form 1 Routes Intramuscular; Intravenous · Intramuscular, Intravenous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveOct 15, 2024
Clinical labels in scope 2
AvailabilityRx
Earliest approval/marketing year 1947
FDA-listed product records 17
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Pyridoxine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Pyridoxine Hydrochloride Injection is a vitamin B6 supplement given by injection when oral B6 can't be taken or absorbed, treating deficiency from poor diet, medications like isoniazid, or inherited metabolic conditions. If you have kidney disease or are a premature newborn, aluminum in the injection requires careful monitoring. If you take levodopa alone (not combined with carbidopa), let your doctor know — pyridoxine can interfere with how that medication works.

📖 Pyridoxine: Patient Information Guide

A plain-language walkthrough of Pyridoxine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Pyridoxine (vitamin B6) injection is used to correct vitamin B6 deficiency when oral supplementation isn't an option. Supported uses include:

  • Pyridoxine deficiency from inadequate dietary intake
  • Drug-induced pyridoxine deficiency — for example, caused by isoniazid (INH) or oral contraceptives
  • Inborn errors of metabolism, including vitamin B6-dependent seizures (convulsions) and vitamin B6-responsive anemia
  • Situations where oral administration is not feasible — such as nausea, vomiting, loss of appetite, or before/after surgery
  • Cases where the gastrointestinal tract cannot properly absorb nutrients
⚙️How it works

Pyridoxine is one form of vitamin B6 found in plants. Once in the body, it and related forms (pyridoxal and pyridoxamine) are converted into the active forms — pyridoxal phosphate and pyridoxamine phosphate — by an enzyme called pyridoxal kinase. These active forms work as coenzymes, helping enzymes carry out essential chemical reactions. Vitamin B6 is involved in breaking down proteins (including converting the amino acid tryptophan into serotonin or niacin), processing carbohydrates, metabolizing fats, and releasing stored glucose from glycogen. When B6 is deficient, all of these processes are impaired.

💊How it's taken

Pyridoxine Hydrochloride Injection is given by a healthcare provider either into a muscle (intramuscularly) or directly into a vein (intravenously). The frequency and duration depend on the underlying reason for the deficiency — some situations require daily injections for several weeks, while others may call for long-term daily use. After injectable treatment for dietary deficiency, follow-up with an oral multivitamin containing pyridoxine is typically recommended.

  • Always follow your prescriber's exact instructions — do not adjust the dose yourself
  • Correcting poor dietary habits is an important part of treatment alongside the injection
🤒Side effects — in detail

Side effects reported with Pyridoxine Hydrochloride Injection include:

  • Paresthesia — tingling, prickling, or numbness sensations
  • Somnolence — unusual drowsiness or sleepiness
  • Low folic acid levels in the blood

If you develop signs of nervous system changes, bone pain, or confusion — especially with long-term use and kidney problems — contact your healthcare provider right away, as these may signal aluminum toxicity.

⚠️Warnings & precautions
  • Aluminum toxicity: This injection contains aluminum. With long-term use, aluminum can build up to toxic levels — particularly in people with kidney disease, whose kidneys cannot clear it efficiently. Toxic aluminum levels can harm the nervous system and bones.
  • Premature newborns at highest risk: Premature babies have immature kidneys and often receive other solutions that also contain aluminum, making them especially vulnerable. The rate of aluminum accumulation needed to cause harm can be quite low in this group.
  • Levodopa interaction: Pyridoxine can reduce the effectiveness of levodopa (used for Parkinson's disease) when levodopa is taken alone. Tell your doctor if you take levodopa.
🔀What it interacts with

Pyridoxine has one key drug interaction to be aware of:

  • Levodopa (alone): Pyridoxine reduces how well levodopa works, so the two should not be used together. However, if you take a combination product containing both carbidopa and levodopa, pyridoxine can be used safely — carbidopa blocks this interaction.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not use Pyridoxine Hydrochloride Injection if you are allergic to pyridoxine or any ingredient in the product
  • Tell your doctor if you have kidney disease — aluminum in the injection can accumulate to harmful levels when kidneys aren't working well
  • Premature newborns require especially careful monitoring due to immature kidneys and high risk of aluminum buildup
  • Tell your doctor if you take levodopa alone (not as a carbidopa/levodopa combination) for Parkinson's disease
🚑If you take too much

In animal studies, very large amounts of pyridoxine caused seizures and death, though a much higher threshold was tolerated in humans in available data. If you suspect an overdose or accidental exposure to a very large amount, seek emergency medical care immediately. Contact the FDA at 1-800-FDA-1088 or your healthcare provider to report any suspected adverse reactions.

📡Pharmacodynamics — effects in the body

Vitamin B6 functions as a coenzyme in the metabolism of proteins, carbohydrates, and fats. It is involved in amino acid reactions including decarboxylation, transamination, and the conversion of tryptophan to niacin or serotonin. It also plays a role in breaking down glycogen into glucose-1-phosphate for energy. The need for pyridoxine increases as protein intake rises, so higher-protein diets require more B6 to support normal metabolism.

🔬Pharmacokinetics — how your body processes it

The total adult body store of pyridoxine is approximately 16 to 25 mg, with a half-life (the time for the body to reduce its level by half) of about 15 to 20 days. Pyridoxine is broken down (metabolized) in the liver to 4-pyridoxic acid, which is then cleared from the body through the urine. Riboflavin (vitamin B2) is required for the conversion of one form of pyridoxine phosphate into the active pyridoxal phosphate form.

📦How to store it

PROTECT FROM LIGHT. Store at 20° to 25°C (68° to 77°F) .

📄 Written from Pyridoxine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Pyridoxine — the kind of thing our pharmacy team would talk through with you at the counter.

Why am I getting a pyridoxine injection instead of just taking a vitamin pill?
The injectable form is used when your body can't absorb B6 through your gut, or when taking something by mouth just isn't possible — like if you're dealing with severe nausea or vomiting, recovering from surgery, or have a condition that affects nutrient absorption. Once those issues resolve, your doctor may switch you to an oral multivitamin containing B6.
My doctor put me on this because I take isoniazid for tuberculosis. Why does that drug cause a B6 deficiency?
Isoniazid (INH) interferes with how your body uses vitamin B6, which can gradually deplete your levels. Pyridoxine injections help replenish that and prevent problems like nerve symptoms that can come from B6 deficiency. It's a common and expected part of TB treatment — you're not doing anything wrong.
I take levodopa for Parkinson's. Is it safe to also take pyridoxine?
It depends on exactly what you take. If you take levodopa by itself, pyridoxine can actually make it less effective — so that combination is something to avoid. But if your Parkinson's medication is a combination of carbidopa and levodopa, pyridoxine is considered safe to use alongside it. Either way, make sure your prescriber knows about all your medications before starting.
What side effects should I watch out for?
The most reported side effects are tingling or numbness (called paresthesia), drowsiness, and low folic acid levels in the blood. These aren't common, but let your doctor know if you notice them. More importantly, if you have kidney disease or are getting long-term injections, watch for signs like bone pain or confusion — those could point to aluminum building up, and your healthcare team needs to know right away.
Is there anything special to know if this is being given to a premature baby?
Yes — premature newborns need extra-careful monitoring. Their kidneys aren't fully developed yet, which makes it harder for their bodies to clear the small amount of aluminum that comes with this injection. Healthcare providers will keep a close eye on aluminum levels and overall kidney function in premature infants receiving this treatment.
How long will I need to take pyridoxine injections?
It really depends on why you need it. For a dietary deficiency, treatment might last a few weeks followed by a switch to an oral multivitamin. If you have an inherited metabolic condition that depends on B6, you may need it long-term. Your prescriber will set the right plan based on your specific situation, so follow their guidance and don't stop on your own.
Is Pyridoxine available over the counter?
Pyridoxine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Pyridoxine first available?
Pyridoxine has been available in the United States since at least 1947, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Pyridoxine?
Pyridoxine is supplied by 12 manufacturers listed in the FDA NDC Directory, including HF Acquisition Co LLC, DBA HealthFirst, DSM Nutritional Products LLC, Fresenius Kabi USA, LLC.

💬 Answers drafted from Pyridoxine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Pyridoxine comes

Pyridoxine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

Into a muscle · Into a vein
Brands Pyridoxine Hci
How this form is used
What it may be used for
  • Treats pyridoxine deficiency from inadequate dietary intake
  • Treats drug-induced pyridoxine deficiency, such as from isoniazid (INH) or oral contraceptives
  • Treats inborn errors of metabolism, including vitamin B6-dependent seizures and vitamin B6-responsive anemia
  • Used when oral pyridoxine is not feasible due to nausea, vomiting, loss of appetite, surgery, or impaired gut absorption
Important instructions
  • Pyridoxine Hci and Pyridoxine Hydrochloride Injection may be given into a muscle (intramuscularly) or into a vein (intravenously)
  • Inspect the solution visually for particles or discoloration before administering
  • After a course of injectable treatment for dietary deficiency, follow-up with an oral multivitamin containing pyridoxine is recommended
  • Correct poor dietary habits and maintain a balanced diet alongside treatment
Available strengths 1 strength
5 FDA-listed product records

📊 Pyridoxine across the U.S. market

How Pyridoxine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
12
Manufacturers
2
Brand names
17
FDA-listed product records
1947
First marketed

Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

HF Acquisition Co LLC, DBA HealthFirst18%
DSM Nutritional Products LLC12%
Fresenius Kabi USA, LLC12%
Spectrum Laboratory Products, Inc.12%
Honour Lab Limited6%
Jiangxi Tianxin Pharmaceutical Co., Ltd.6%
Other makers35%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Pyridoxine is used

A general measure of how commonly Pyridoxine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Pyridoxine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

6,433
Medicaid prescriptions filled (Q1–Q4 2025)
$207,752 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Pyridoxine prescribed? Of the 1,596 medications we measure, Pyridoxine ranks #1,009 by Medicaid prescriptions — more than 37% of them.

Where Pyridoxine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Pyridoxine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

pyridoxine hydrochloride 100 MG/ML Injectable Solution

6,433 Medicaid prescriptions (Q1–Q4 2025) 100% of Pyridoxine prescriptions shown $207,752 gross reimbursement (before rebates) ≈ $32 per prescription (gross)

Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 312736

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Pyridoxine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 6 listed Pyridoxine NDCs with Medicaid activity.

🔍 Compare Pyridoxine products

A representative set of FDA-listed product records for Pyridoxine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 17 of 17 products — FDA National Drug Code Directory. See every product, package size and price: browse all 17 Pyridoxine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Pyridoxine RxCUI 684879 2 dose forms · 2 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 1804722 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 100 MG/ML RxCUI 312736
  2. Dose form (SCDF) Oral Tablet RxCUI 1100456 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 25 MG RxCUI 1100457

Look up RxCUI 684879 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Hexa-betalin Pyridoxine Hci

🏭 Manufacturers & labelers

HF Acquisition Co LLC, DBA HealthFirst 3 DSM Nutritional Products LLC 2 Fresenius Kabi USA, LLC 2 Spectrum Laboratory Products, Inc. 2 Honour Lab Limited 1 Jiangxi Tianxin Pharmaceutical Co., Ltd. 1 Olon, SpA 1 Particle Dynamics International, LLC 1 Professional Compounding Centers of America 1 Qingdao Tida Biotek Co.,ltd 1 Sthree Chemicals Private Limited 1 Willow Birch Pharma, LLC 1

RxNorm drug class

Pyridoxine belongs to the Vitamin B6 Analog class.

Pharmacologic class Vitamin B6 Analog
Drug family (ATC) Other plain vitamin preparations

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Pyridoxine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Pyridoxine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
17
Distinct labelers/manufacturers represented
12
Linked representative label
Fresenius Kabi USA, LLC
Linked label effective
Oct 15, 2024
Composite sections available
14
Linked SPL Set ID
a56d11c0-b033-4201-85ff-fc710506481a
Linked SPL Document ID
621c0b5c-be50-4bb5-9475-6acba6114cbe
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.