Pyridoxine Hydrochloride 100 mg/mL Injection, Solution, 25 vials
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Vitamin B6 Analog class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- 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 vo...
- Why am I getting a pyridoxine injection instead of just taking a vitamin pill?
- 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 sy...
- My doctor put me on this because I take isoniazid for tuberculosis. Why does that drug cause a B6 deficiency?
Patient education
Supplement & herbal interactions
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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5 mg / 1 mL
UNII HM4YQM8WRC
Chlorobutanol is a colorless crystalline chemical used as a preservative in medicines. It prevents bacterial and fungal growth to maintain product safety and shelf life.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
2 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $13.30 | $332.53 / 25 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J3415 | $12.941 / J3415 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pyridoxine Hci 100 mg/mL 51662-1410-01 | HF | 1 ml | — | — | FDA listed | — |
| Pyridoxine Hydrochloride 100 mg/mLthis 63323-0180-01 | Fresenius | 25 vials | — | — | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
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Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 63323-0180-01 You're viewing this | 25 VIAL in 1 TRAY (63323-180-01) / 1 mL in 1 VIAL (63323-180-00) | 2000-09-05 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Pyridoxine Hydrochloride Injection is effective for the treatment of pyridoxine deficiency as seen in the following: Inadequate dietary intake. Drug-induced deficiency, as from isoniazid (INH) or oral contraceptives. Inborn errors of metabolism, e.g., vitamin B 6 dependent convulsions or vitamin B 6 responsive anemia.
The parenteral route is indicated when oral administration is not feasible as in anorexia, nausea and vomiting, and preoperative and postoperative conditions. It is also indicated when gastrointestinal absorption is impaired.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Pyridoxine Hydrochloride Injection may be administered intramuscularly or intravenously. In cases of dietary deficiency, the dosage is 10 to 20 mg daily for 3 weeks. Follow-up treatment is recommended daily for several weeks with an oral therapeutic multivitamin preparation containing 2 to 5 mg pyridoxine.
Poor dietary habits should be corrected, and an adequate, well balanced diet should be prescribed. The vitamin B 6 dependency syndrome may require a therapeutic dosage of as much as 600 mg a day and a daily intake of 30 mg for life. In deficiencies due to INH, the dosage is 100 mg daily for 3 weeks followed by a 30 mg maintenance dose daily.
In poisoning caused by ingestion of more than 10 g of INH, an equal amount of pyridoxine should be given — 4 g intravenously followed by 1 g intramuscularly every 30 minutes. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
⛔ Contraindications ▾
CONTRAINDICATIONS: A history of sensitivity to pyridoxine or to any of the ingredients in Pyridoxine Hydrochloride Injection, USP is a contraindication.
⚠️ Warnings ▾
WARNINGS: WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Paresthesia, somnolence, and low serum folic acid levels have been reported.
🔄 Drug Interactions ▾
Drug Interactions Pyridoxine supplements should not be given to patients receiving levodopa, because the action of the latter drug is antagonized by pyridoxine. However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.
🤰 Pregnancy ▾
Pregnancy Pregnancy Category A —The requirement for pyridoxine appears to be increased during pregnancy. Pyridoxine is sometimes of value in the treatment of nausea and vomiting of pregnancy.
🧒 Pediatric Use ▾
Usage in Children Safety and effectiveness in children have not been established.
🆘 Overdosage ▾
OVERDOSAGE: Pyridoxine given to animals in amounts of 3 to 4 g/kg of body weight produces convulsions and death. In man, a dose of 25 mg/kg of body weight is well tolerated.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Natural substances that have vitamin B 6 activity are pyridoxine in plants and pyridoxal or pyridoxamine in animals. All 3 are converted to pyridoxal phosphate by the enzyme pyridoxal kinase. The physiologically active forms of vitamin B 6 are pyridoxal phosphate (codecarboxylase) and pyridoxamine phosphate.
Riboflavin is required for the conversion of pyridoxine phosphate to pyridoxal phosphate. Vitamin B 6 acts as a coenzyme in the metabolism of protein, carbohydrate, and fat. In protein metabolism, it participates in the decarboxylation of amino acids, conversion of tryptophan to niacin or to serotonin (5-hydroxtryptamine), deamination, and transamination and transulfuration of amino acids.
In carbohydrate metabolism, it is responsible for the breakdown of glycogen to glucose-1-phosphate. The total adult body pool consists of 16 to 25 mg of pyridoxine. Its half-life appears to be 15 to 20 days.
Vitamin B 6 is degraded to 4-pyridoxic acid in the liver. This metabolite is excreted in the urine. The need for pyridoxine increases with the amount of protein in the diet.
The tryptophan load test appears to uncover early vitamin B 6 deficiency by detecting xanthinurea. The average adult minimum daily requirement is about 1.25 mg. The ‘‘Recommended Dietary Allowance’’ of the National Academy of Sciences is estimated to be as much as 2.2 mg for adults and 2.5 mg for pregnant and lactating women.
The requirements are more in persons having certain genetic defects or those being treated with isonicotinic acid hydrazide (INHJ) or oral contraceptives.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Pyridoxine Hydrochloride Injection, USP is supplied as: Product Code Unit of Sale Strength Each 1801 NDC 63323-180-01 Unit of 25 100 mg per mL NDC 63323-180-00 1 mL fill, in a 2 mL multiple dose vial PROTECT FROM LIGHT. Use only if solution is clear and seal intact. Sterile. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION: Pyridoxine Hydrochloride Injection, USP is a sterile solution of pyridoxine hydrochloride in Water for Injection. Each mL contains 100 mg pyridoxine hydrochloride and 0.5% chlorobutanol anhydrous (chloral deriv.). pH adjusted with sodium hydroxide if necessary (2.0 to 3.8). Pyridoxine hydrochloride is a colorless or white crystal or a white crystalline powder.
One gram dissolves in 5 mL of water. It is stable in air and is slowly affected by sunlight. The chemical name is 2-methyl-3-hydroxy-4,5-bis (hydroxymethyl) pyridine hydrochloride.
The structural formula is: Structural Formula