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Pyridoxine Hydrochloride 100 mg/mL Injection, Solution, 25 vials — NDC 63323-180-01 (Billing 63323-0180-01)

by Fresenius Kabi USA, LLC · 25 VIAL in 1 TRAY / 1 mL in 1 VIAL

This is a package of 25 vials of Pyridoxine Hydrochloride 100 mg/mL Injection, Solution from Fresenius Kabi USA, LLC, marketed since Aug 1972 and currently FDA-listed. It is this product's only package size.

NDC 63323-0180-01
🏷️ FDA NDC (as labeled) 63323-180-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63323-180-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63323 labeler · 180 product · 01 package
Package marketed since
Sep 5, 2000
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6332318001 0
Medicaid fills, this package
6,539 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63323-180-01
Product NDC 63323-180
11-digit billing NDC 63323018001
NCPDP billing unit ML — per mL (volume)
RxCUI 312736
UNII 68Y4CF58BV
Application # ANDA080618
SPL Set ID a56d11c0-b033-4201-85ff-fc710506481a
Established class (EPC) Vitamin B6 Analog
Chemical class Analogs/Derivatives; Vitamin B 6
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1972-08-14
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance PYRIDOXINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 77105010002005
GPI class Pyridoxine HCl
GCN Seq No 002419
GCN 94961
HICL code 001071
Ingredient (HICL) Pyridoxine Hcl (Vitamin B6)
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6Q
Therapeutic class — specific (HIC3) Vitamin B6 Preparations
AHFS code 88:08.00.00
AHFS class Vitamin B Complex
FDB label name PYRIDOXINE 100 MG/ML VIAL
FDB brand name Pyridoxine Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002419
  • GCN: 94961
  • GPI-14 (Medi-Span): 77105010002005
  • HICL (First Databank): 001071
  • AHFS class code: 88:08.00.00
  • RxCUI (RxNorm): 312736
Why two NDCs? The FDA registers this code as 63323-180-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63323-0180-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Vitamin B6 Analog class.

Pharmacologic class Vitamin B6 Analog
Drug family (ATC) Other plain vitamin preparations
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PYRIDOXINE 100 MG/ML VIAL Ingredient Pyridoxine Hcl (Vitamin B6)
📗 Our plain-language guide HelloPharmacist
  • It treats vitamin B6 deficiency, whether from poor diet, medicines like isoniazid or oral contraceptives, or certain inherited conditions. It's also used when you can't take it by...
  • A healthcare professional gives it into a muscle or a vein. It's usually daily for a few weeks, and you may then switch to an oral multivitamin with pyridoxine. Your diet should im...
  • Tingling or odd sensations, sleepiness, and low folic acid levels have been reported. Tell your care team about anything that bothers you.
  • Yes, levodopa. Pyridoxine can work against it, so supplements shouldn't be given with levodopa alone. It can be used with carbidopa-levodopa combinations.
📖 Read our full Pyridoxine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $14.23 $355.65 / 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 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)63323-180-01
11-digit billing NDC63323-0180-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3415
DescriptorINJECTION, PYRIDOXINE HCL, 100 MG
Billing units / pkg1 units
How the units are derivedThis package is 1 ML; the HCPCS unit is 100 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$283,323 · 12,475 claims · $22.71 per claim (all NDCs under J3415)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63323-0180-01 You're viewing this Main listing 25 VIAL in 1 TRAY / 1 mL in 1 VIAL 2000-09-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
1972
On the market since
Aug 1972
📍
2026
Currently FDA-listed
54 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Pyridoxine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 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.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationANDA080618 (ANDA)
Labeler code63323
First marketedAug 1972
Product typeHuman Prescription Drug
Portfolio554 products on file

More NDCs from Fresenius Kabi USA, LLC labeler code 63323

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🔒 Drug Abuse and Dependence 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 78 words ▾

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 165 words ▾

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 21 words ▾

CONTRAINDICATIONS: A history of sensitivity to pyridoxine or to any of the ingredients in Pyridoxine Hydrochloride Injection, USP is a contraindication.

⚠️ Warnings 94 words ▾

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 31 words ▾

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 40 words ▾

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 28 words ▾

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 12 words ▾

Usage in Children Safety and effectiveness in children have not been established.

🆘 Overdosage 32 words ▾

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 ~1 min read ▾

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 64 words ▾

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 85 words ▾

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

⚠️ Precautions 172 words ▾

PRECAUTIONS: General Single deficiency, as of pyridoxine alone, is rare. Multiple vitamin deficiency is to be expected in any inadequate diet. Patients treated with levodopa should avoid supplemental vitamins that contain more than 5 mg pyridoxine in the daily dose.

Women taking oral contraceptives may exhibit increased pyridoxine requirements. 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 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. Nursing Mothers The need for pyridoxine is increased during lactation.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pyridoxine hydrochloride is administered to a nursing woman. Usage in Children Safety and effectiveness in children have not been established.

🍼 Nursing Mothers 43 words ▾

Nursing Mothers The need for pyridoxine is increased during lactation. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pyridoxine hydrochloride is administered to a nursing woman.

🔒 Drug Abuse and Dependence 20 words ▾

DRUG ABUSE AND DEPENDENCE: Symptoms of dependence have been noted in adults given only 200 mg daily, followed by withdrawal.

📄 Package Label / Principal Display Panel 98 words ▾

PACKAGE LABEL - PRINCIPAL DISPLAY - Pyridoxine HCl 1 mL Multiple Dose Vial Label NDC 63323-180-00 1801 PYRIDOXINE HCl INJECTION, USP 100 mg per mL For IM or IV Use 1 mL Multiple Dose Vial Usual Dosage: See insert. Rx only vial label

PACKAGE LABEL - PRINCIPAL DISPLAY - Pyridoxine HCl 1 mL Multiple Dose Vial Tray Label NDC 63323-180-01 1801 PYRIDOXINE HCl INJECTION, USP 100 mg per mL For Intramuscular or Intravenous Use 1 mL Rx only Multiple Dose Vial 25 Vials PACKAGE LABEL - PRINCIPAL DISPLAY - Pyridoxine HCl 1 mL Multiple Dose Vial Tray Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
6.5K
Units reimbursed last 4 qtrs
16.3K
Gross reimbursed last 4 qtrs
$232.1K
Avg / prescription
$35.49
Avg / unit
$14.2261
Latest quarter Q1 2026
1.3KRx
Fee-for-service vs managed care ⓘ
31% FFS 69% MCO
Fee-for-service · 2,036 Rx Managed care · 4,503 Rx
State Medicaid map
Alaska: 63 units · 8.6 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: 133 units · 6.8 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 1,531 units · 15.3 per 100k residents MI New York: 3,739 units · 19.1 per 100k residents NY Vermont: no data reported VT New Hampshire: 17 units · 1.2 per 100k residents NH Oregon: 67 units · 1.6 per 100k residents OR Nevada: 12 units · 0.4 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 730 units · 5.8 per 100k residents IL Indiana: 158 units · 2.3 per 100k residents IN Ohio: 503 units · 4.3 per 100k residents OH Pennsylvania: 12 units · 0.1 per 100k residents PA New Jersey: 229 units · 2.5 per 100k residents NJ Massachusetts: 24 units · 0.3 per 100k residents MA California: 4,141 units · 10.6 per 100k residents CA Utah: 51 units · 1.5 per 100k residents UT Colorado: 40 units · 0.7 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 12 units · 0.1 per 100k residents VA Maryland: 1,916 units · 31.0 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 12 units · 0.2 per 100k residents TN North Carolina: 57 units · 0.5 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 169 units · 3.3 per 100k residents AL Georgia: 12 units · 0.1 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 337 units · 1.1 per 100k residents TX Florida: 2,347 units · 10.4 per 100k residents FL
Units reimbursed · per 100k residents
0.131.0
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maryland 31.0 /100k
2 New York 19.1 /100k
3 Michigan 15.3 /100k
4 California 10.6 /100k
5 Florida 10.4 /100k
6 Alaska 8.6 /100k
7 Idaho 6.8 /100k
8 Illinois 5.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PYRIDOXINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Nausea505
Vomiting466
Pain411
General Physical Health Deterioration362
Headache359
Fatigue348
Abdominal Pain328

Reporter sex

3,886 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Disabling466
Life-threatening431
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 337 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC No photo available yet for this listing.
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
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J3415 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63323-0178-76 · Fresenius 63323-0184-10 · Fresenius →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.