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Vitamin K1 PHYTONADIONE 10 mg/mL Injection, Emulsion — NDC 00409-9158-01 package photo
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Vitamin K1 PHYTONADIONE 10 mg/mL Injection, Emulsion — NDC 0409-9158-01 (Billing 00409-9158-01)

by Hospira, Inc. · 5 TRAY in 1 CONTAINER / 5 AMPULE in 1 TRAY / 1 mL in 1 AMPULE

This is a package of Vitamin K1 PHYTONADIONE 10 mg/mL Injection, Emulsion from Hospira, Inc., marketed since Jul 2005 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00409-9158-01
🏷️ FDA NDC (as labeled) 0409-9158-01 billing pads the labeler segment with a zero
This package
Contains1 mL in 1 ampule Medicaid pays$50.35 / unit · 12 mo Per package$1,258.85 / 25 ml · Medicaid Pack sizes2 compare ↓
Main listing for product 0409-9158 · Also comes in: 5 ampules 0409-9158-25
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 20, 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 0409-9158-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0409 labeler · 9158 product · 01 package
Package marketed since
Jul 27, 2005
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0409915801 8
Medicaid fills, this package
1,548 prescriptions in the last four reported quarters
FDA record last changed
Aug 20, 2026
⚠️
Other active recalls for Phytonadione (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — Failed Stability Specifications: Observed OOS results: eg results for colour index (Cipla Limited) · FDA recall D-0197-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0409-9158-01
Product NDC 0409-9158
11-digit billing NDC 00409915801
NCPDP billing unit ML — per mL (volume)
RxCUI 312424, 1670192
UNII A034SE7857
Application # ANDA087955
SPL Set ID e8808230-2c44-44c6-8cab-8f29b6b34051
Established class (EPC) Vitamin K; Warfarin Reversal Agent
Physiologic effect Increased Prothrombin Activity; Reversed Anticoagulation Activity
Chemical class Vitamin K
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2005-07-27
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, EMULSION
Substance PHYTONADIONE
TE code (Orange Book) AB1 · RLD · RS

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

GCN Seq No 002301
GCN 94725
HICL code 001040
Ingredient (HICL) Phytonadione (Vit K1)
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C6
Therapeutic class — intermediate (HIC2) Vitamins
HIC3 code C6K
Therapeutic class — specific (HIC3) Vitamin K Preparations
AHFS code 88:24.00.00
AHFS class Vitamin K Activity
FDB label name VITAMIN K-1 10 MG/ML AMPUL
FDB brand name Vitamin K1
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002301
  • GCN: 94725
  • HICL (First Databank): 001040
  • AHFS class code: 88:24.00.00
  • RxCUI (RxNorm): 312424
Why two NDCs? The FDA registers this code as 0409-9158-01 — a 4-4-2 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 labeler segment → 00409-9158-01. 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 Warfarin Reversal Agent class.

Pharmacologic class Warfarin Reversal Agent, Vitamin K
Drug family (ATC) Vitamin K
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 VITAMIN K-1 10 MG/ML AMPUL Ingredient Phytonadione (Vit K1)
📖 What it is MedlinePlus · NLM

Phytonadione injection is used to prevent bleeding in people with blood clotting problems or too little vitamin K in the body. Phytonadione injection is also used to prevent and treat bleeding in newborn babies. Phytonadione is in a class of medications called vitamins. It works by providing vitamin K that is needed for blood to clot normally in the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's vitamin K1. It helps your blood clot when vitamin K is low or blocked, for example by a blood thinner like warfarin, some antibiotics, or conditions that limit absorption. The...
  • The tablets are taken by mouth, and your prescriber may add bile salts if your body doesn't make enough bile. The injection is given by a healthcare professional, preferably under...
  • It isn't instant. Your INR may take 1 to 8 hours to improve, and after an IV dose a normal INR is often reached in about 12 to 14 hours. If bleeding is severe, you may need other t...
  • Some people feel dizzy, flushed, or sweaty, notice an odd taste, or have a fast heartbeat. Injection-site soreness can happen. Get emergency help for trouble breathing, chest pain,...
📖 Read our full Phytonadione 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 $50.35 $1,258.85 / 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 · J3430 $3.253 / J3430 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)0409-9158-01
11-digit billing NDC00409-9158-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ3430
DescriptorInjection, phytonadione (vitamin k), per 1 mg
Billing units / pkg250 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 250 billing units.
Medicare Part B spend (2026 (Q1))$874 · 39 claims · $22.41 per claim (all NDCs under J3430)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
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
00409-9158-01 You're viewing this Main listing 5 TRAY in 1 CONTAINER / 5 AMPULE in 1 TRAY / 1 mL in 1 AMPULE 2005-07-27 — Active
00409-9158-25 0409-9158-25 5 TRAY in 1 CONTAINER / 5 AMPULE in 1 TRAY / 1 mL in 1 AMPULE 2021-01-15 — Active

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 5 tray in 1 container / 5 ampule in 1 tray / 1 ml in 1 ampule.
What NDC number is used to bill for this package of Vitamin K1 PHYTONADIONE 10 mg/mL Injection, Emulsion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phytonadione 10 mg/mL 00404-9969-01 Henry 1 ampule — AB1 FDA listed —
Vitamin K1 10 mg/mLthis 00409-9158-01 Hospira, 5 ampules — AB1 FDA listed —
Phytonadione Phytonadione 10 mg/mL 43598-0405-16 Dr.Reddy's 25 ampules — AB1 FDA listed —
Vitamin K1 - Phytonadione 10 mg/mL 51662-1536-03 HF 25 pouches — AB1 FDA listed —
Phytonadione 10 mg/mL 65145-0151-10 Caplin 5 vials — AB1 FDA listed —
Phytonadione 10 mg/mL 65219-0635-01 Fresenius 5 vials — AB1 FDA listed —
Phytonadione 10 mg/mL 68083-0606-25 Gland 5 ampules — AB1 FDA listed —
Phytonadione 10 mg/mL 68462-0758-25 GLENMARK 5 ampules — AB1 FDA listed —
Phytonadione 10 mg/mL 69097-0708-96 Cipla 10 vials — — FDA listed —
Phytonadione 10 mg/mL 70700-0331-25 Xiromed 5 ampules — AB1 FDA listed —
Phytonadione 10 mg/mL 80830-1683-03 Amneal 5 vials — AB1 FDA listed —
Phytonadione 10 mg/mL 51662-1698-03 HF 25 pouches — AB1 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

🏛️
2005
On the market since
Jul 2005
📍
2026
Currently FDA-listed
21 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 Phytonadione 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerHospira, Inc.
Application holderHOSPIRA INC
FDA applicationANDA087955 (ANDA)
Labeler code00409
First marketedJul 2005
Product typeHuman Prescription Drug
Portfolio317 products on file

More NDCs from Hospira, Inc. labeler code 00409

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 145 words ▾

WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Warnings and Precautions (5.1) ] .

WARNING: HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE See full prescribing information for complete boxed warning. Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after INTRAVENOUS and INTRAMUSCULAR injection of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid infusion and upon first and subsequent doses.

Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified. ( 5.1 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE Vitamin K 1 Injection is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. • Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. ( 1.1 ) • Hypoprothrombinemia due to antibacterial therapy. ( 1.1 ) • Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis.

( 1.1 ) • Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. ( 1.1 ) Vitamin K 1 Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. ( 1.2 )

1.1Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Vitamin K 1 Injection is indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity: • anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives; • hypoprothrombinemia due to antibacterial therapy; • hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; • other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

1.2Prophylaxis and Treatment of Vitamin K-Deficiency Bleeding in Neonates Vitamin K 1 Injection is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Administer Vitamin K 1 Injection by the subcutaneous route, whenever possible. ( 2.1 ) • When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute. ( 2.1 )

2.1Dosing Considerations Whenever possible, administer Vitamin K 1 Injection by the subcutaneous route [see Boxed Warning ] . When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 mg per minute [see Warnings and Precautions (5.1) ] . Monitor international normalized ratio (INR) regularly and as clinical conditions indicate.

Use the lowest effective dose of Vitamin K 1 Injection. The coagulant effects of Vitamin K 1 Injection are not immediate; improvement of INR may take 1 to 8 hours. Interim use of whole blood or component therapy may also be necessary if bleeding is severe.

Whenever possible, administer benzyl alcohol-free phytonadione formulations in pediatric patients [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . When Vitamin K 1 Injection is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. Vitamin K 1 Injection is not a clotting agent, but overzealous therapy with Vitamin K 1 Injection may restore conditions which originally permitted thromboembolic phenomena.

Dosage should be kept as low as possible, and INR should be checked regularly as clinical conditions indicate.

2.2Recommended Dosage for Coagulation Disorders from Vitamin K Deficiency or Interference The recommended dosage of Vitamin K 1 Injection is based on whether the hypoprothrombinemia is anticoagulant-induced (e.g., due to coumarin or indanedione derivatives) or non-anticoagulant-induced (e.g., due to antibiotics; salicylates or other drugs; factors limiting absorption or synthesis) as follows: • Anticoagulant-Induced Hypoprothrombinemia: Vitamin K 1 Injection 2.5 mg to 10 mg or more subcutaneously, intramuscularly, or intravenously.

Up to 25 mg to 50 mg may be administered as a single dose. Repeated large doses of Vitamin K 1 Injection are not warranted in liver disease if the initial response is unsatisfactory. Failure to respond to Vitamin K 1 Injection may indicate that the condition being treated is inherently unresponsive to Vitamin K 1 Injection. • Hypoprothrombinemia Due to Other Causes (Non-Anticoagulation-Induced Hypoprothrombinemia): Vitamin K 1 Injection 2.5 mg to 25 mg or more intravenously, intramuscularly, or subcutaneously.

Up to 50 mg may be administered as a single dose. Evaluate INR after 6 to 8 hours, and repeat dose if INR remains prolonged. Modify subsequent dosage (amount and frequency) based on the INR or clinical condition.

2.3Recommended Dosage for Prophylaxis and Treatment of Vitamin K Deficiency Bleeding in Neonates Prophylaxis of Vitamin K-Deficiency Bleeding in Neonates The recommended dosage of Vitamin K 1 Injection is 0.5 mg to 1 mg within one hour of birth for a single dose. Treatment of Vitamin K Deficiency Bleeding in Neonates The recommended dosage of Vitamin K 1 Injection is 1 mg given either subcutaneously or intramuscularly. Consider higher doses if the mother has been receiving oral anticoagulants.

A failure to respond (shortening of the INR in 2 to 4 hours) may indicate another diagnosis or coagulation disorder.

2.4Directions for Dilution Dilute Vitamin K 1 Injection with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Avoid use of other diluents that may contain benzyl alcohol, which can cause serious toxicity in newborns or low birth weight infants [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ]. When diluted, start administration of Vitamin K 1 Injection immediately after dilution.

Discard unused portions of diluted solution as well as unused contents of the ampul. Pr… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 26 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1 mg/0.5 mL and 10 mg/mL single-dose ampuls. Injection: 1 mg/0.5 mL and 10 mg/mL single-dose ampuls. ( 3 )

⛔ Contraindications 29 words ▾

4 CONTRAINDICATIONS Hypersensitivity to phytonadione or any other component of this medication [see Warnings and Precautions (5.1) ] . Hypersensitivity to any component of this medication. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Use benzyl alcohol-free phytonadione formulations in neonates and infants, if available. ( 5.2 ) • Cutaneous Reactions: May occur with parenteral use. Discontinue drug and manage medically. ( 5.3 )

5.1Hypersensitivity Reactions Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of Vitamin K 1 Injection. Reactions have occurred despite dilution to avoid rapid intravenous infusion and upon first dose. These reactions have included shock, cardiorespiratory arrest, flushing, diaphoresis, chest pain, tachycardia, cyanosis, weakness, and dyspnea.

Administer Vitamin K 1 Injection subcutaneously whenever feasible. Avoid the intravenous and intramuscular routes of administration unless the subcutaneous route is not feasible and the serious risk is justified [see Dosage and Administration (2.1) ] .

5.2Risk of Serious Adverse Reaction in Infants due to Benzyl Alcohol Preservative Use benzyl alcohol-free phytonadione formulations in neonates and infants, if available. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and infants treated with benzyl alcohol‑preserved drugs, including Vitamin K 1 Injection. The “gasping syndrome” is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.

When prescribing Vitamin K 1 Injection in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including Vitamin K 1 Injection (contains 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Use in Specific Populations (8.1 , 8.2 and 8.4) ] .

5.3Cutaneous Reactions Parenteral administration of vitamin K replacements (including Vitamin K 1 Injection) may cause cutaneous reactions. Reactions have included eczematous reactions, scleroderma-like patches, urticaria, and delayed-type hypersensitivity reactions. Time of onset ranged from 1 day to a year after parenteral administration. Discontinue Vitamin K 1 Injection for skin reactions and institute medical management.

5.4Aluminum Toxicity 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 208 words ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] • Cutaneous Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1‑800‑438‑1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of Vitamin K 1 Injection. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: Tachycardia, hypotension.

General Disorders and Administration Site Conditions: Generalized flushing; pain, swelling, and tenderness at injection site. Hepatobiliary Disorders: Hyperbilirubinemia. Immune System Disorders: Fatal hypersensitivity reactions, anaphylactic reactions.

Neurologic: Dysgeusia, dizziness. Pulmonary: Dyspnea. Skin and Subcutaneous Tissue Disorders: Erythema, pruritic plaques, scleroderma-like lesions, erythema perstans.

Vascular: Cyanosis.

🔄 Drug Interactions 81 words ▾

7 DRUG INTERACTIONS Anticoagulants Vitamin K 1 Injection may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of Vitamin K 1 Injection are used. Should this occur, higher doses of anticoagulant therapy may be needed when resuming anticoagulant therapy, or a change in therapy to a different class of anticoagulant may be necessary (i.e., heparin sodium). Vitamin K 1 Injection does not affect the anticoagulant action of heparin.

Anticoagulants: May induce temporary resistance to prothrombin-depressing anticoagulants. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: If available, use a preservative-free phytonadione formulation in pregnant women. ( 8.1 ) • Lactation: If available, use a preservative-free phytonadione formulation in lactating women. ( 8.2 ) • Pediatric Use: The safety and effectiveness of Vitamin K 1 Injection in pediatric patients from 6 months to 17 years have not been established. ( 8.4 )

8.1Pregnancy Risk Summary Vitamin K 1 Injection contains benzyl alcohol, which has been associated with gasping syndrome in neonates. The preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants . If Vitamin K 1 Injection is needed during pregnancy, consider using a benzyl alcohol-free phytonadione formulation [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] .

Published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see Data ]. There are maternal and fetal risks associated with vitamin K deficiency during pregnancy [see Clinical Considerations ] . Animal reproduction studies have not been conducted with phytonadione.

The estimated background risk for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Pregnant women with vitamin K deficiency hypoprothrombinemia may be at an increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. Subclinical maternal vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. Data Human Data Phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma.

Administration of vitamin K 1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. Published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding.

Animal Data In pregnant rats receiving vitamin K 1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer.

8.2Lactation Risk Summary Vitamin K 1 Injection contains benzyl alcohol. If available, a preservative-free phytonadione formulation is recommended when Vitamin K 1 Injection is needed during lactation [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] . Phytonadione is present in breastmilk.

There are no data on the effects of Vitamin K 1 Injection on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the clinical need for Vitamin K 1 Injection and any potential adverse effects on the breastfed child from Vitamin K 1 Injection or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Vitamin K 1 Injection for prophylaxis and treatment of vitamin K deficiency have been established in neonates. Use of phytonadione injection for prophylaxis and treatment of vitamin K deficiency is based on published clinical studies. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative.

In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood a… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Vitamin K 1 Injection contains benzyl alcohol, which has been associated with gasping syndrome in neonates. The preservative benzyl alcohol can cause serious adverse events and death when administered intravenously to neonates and infants . If Vitamin K 1 Injection is needed during pregnancy, consider using a benzyl alcohol-free phytonadione formulation [see Warnings and Precautions (5.2) , Use in Specific Populations (8.4) ] .

Published studies with the use of phytonadione during pregnancy have not reported a clear association with phytonadione and adverse developmental outcomes [see Data ]. There are maternal and fetal risks associated with vitamin K deficiency during pregnancy [see Clinical Considerations ] . Animal reproduction studies have not been conducted with phytonadione.

The estimated background risk for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Pregnant women with vitamin K deficiency hypoprothrombinemia may be at an increased risk for bleeding diatheses during pregnancy and hemorrhagic events at delivery. Subclinical maternal vitamin K deficiency during pregnancy has been implicated in rare cases of fetal intracranial hemorrhage. Data Human Data Phytonadione has been measured in cord blood of infants whose mothers were treated with phytonadione during pregnancy in concentrations lower than seen in maternal plasma.

Administration of vitamin K 1 to pregnant women shortly before delivery increased both maternal and cord blood concentrations. Published data do not report a clear association with phytonadione and adverse maternal or fetal outcomes when used during pregnancy. However, these studies cannot definitively establish the absence of any risk because of methodologic limitations including small sample size and lack of blinding.

Animal Data In pregnant rats receiving vitamin K 1 orally, fetal plasma and liver concentrations increased following administration, supporting placental transfer.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of Vitamin K 1 Injection for prophylaxis and treatment of vitamin K deficiency have been established in neonates. Use of phytonadione injection for prophylaxis and treatment of vitamin K deficiency is based on published clinical studies. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and infants in the intensive care unit who received drugs containing benzyl alcohol as a preservative.

In these cases, benzyl alcohol dosages of 99 to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.

When prescribing Vitamin K 1 Injection in infants consider the combined daily metabolic load of benzyl alcohol from all sources including Vitamin K 1 Injection (Vitamin K 1 Injection contains 9 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.2) ] . Whenever possible, use preservative-free phytonadione formulations in neonates.

The preservative benzyl alcohol has been associated with serious adverse events and death in pediatric patients. Premature and low birth weight infants may be more likely to develop toxicity.

🆘 Overdosage 20 words ▾

10 OVERDOSAGE Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may result from Vitamin K 1 Injection overdose.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Vitamin K 1 Injection aqueous dispersion of vitamin K 1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post‑translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X.

The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood. In normal animals and humans, phytonadione is virtually devoid of activity. However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function, that is, to promote the hepatic biosynthesis of vitamin K dependent clotting factors.

12.2Pharmacodynamics The action of the aqueous dispersion, when administered intravenously, is generally detectable within an hour or two and hemorrhage is usually controlled within 3 to 6 hours. A normal INR may often be obtained in 12 to 14 hours.

12.3Pharmacokinetics Absorption Phytonadione is readily absorbed following intramuscular administration. Distribution After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Elimination Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.

🧬 Mechanism of Action 158 words ▾

12.1Mechanism of Action Vitamin K 1 Injection aqueous dispersion of vitamin K 1 for parenteral injection, possesses the same type and degree of activity as does naturally-occurring vitamin K, which is necessary for the production via the liver of active prothrombin (factor II), proconvertin (factor VII), plasma thromboplastin component (factor IX), and Stuart factor (factor X). Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the post‑translational carboxylation of multiple, specific, peptide-bound glutamic acid residues in inactive hepatic precursors of factors II, VII, IX, and X.

The resulting gamma-carboxy-glutamic acid residues convert the precursors into active coagulation factors that are subsequently secreted by liver cells into the blood. In normal animals and humans, phytonadione is virtually devoid of activity. However, in animals and humans deficient in vitamin K, the pharmacological action of vitamin K is related to its normal physiological function, that is, to promote the hepatic biosynthesis of vitamin K dependent clotting factors.

📦 How Supplied / Storage and Handling 78 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Vitamin K 1 Injection (Phytonadione Injectable Emulsion, USP) is a yellow, sterile, nonpyrogenic aqueous dispersion and is supplied as follows: Unit of Sale Concentration NDC 0409-9157-01 Bundle of 5 clamcells containing 5 single-dose ampuls 1 mg/0.5 mL NDC 0409-9158-01 Bundle of 5 clamcells containing 5 single-dose ampuls 10 mg/mL Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from light. Keep ampuls in tray until time of use.

📋 Description 154 words ▾

11 DESCRIPTION Phytonadione is a vitamin K replacement, which is a clear, yellow to amber, viscous, odorless or nearly odorless liquid. It is insoluble in water, soluble in chloroform and slightly soluble in ethanol. It has a molecular weight of 450.70.

Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C 31 H 46 O 2 and its molecular structure is: Vitamin K 1 Injection (Phytonadione Injectable Emulsion, USP) is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Vitamin K 1 Injection is available in 1 mg (1 mg/0.5 mL) and 10 mg (10 mg/mL) single-dose ampuls.

Each milliliter contains phytonadione 2 mg or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive. structural formula phytonadione

💬 Information for Patients 156 words ▾

17 PATIENT COUNSELING INFORMATION Inform the patient of the following important risks of Vitamin K 1 Injection: Serious Hypersensitivity Reactions Advise the patient and caregivers to immediately report signs of hypersensitivity after receiving Vitamin K 1 Injection [see Warnings and Precautions (5.1) ]. Risk of Gasping Syndrome Due to Benzyl Alcohol Advise the patient and caregivers of the risk of gasping syndrome associated with the use of products that contain benzyl alcohol (including Vitamin K 1 Injection) in neonates, infants, and pregnant women [see Warnings and Precautions (5.2) ].

Cutaneous Reactions Advise the patient and caregivers to report the occurrence of new rashes after receiving Vitamin K 1 Injection. These reactions may be delayed for up to a year after treatment [see Warnings and Precautions (5.3) ]. This product’s labeling may have been updated.

For the most recent prescribing information, please visit www.pfizer.com . Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1141-3.0 Hospira logo

🧬 Pharmacokinetics 54 words ▾

12.3Pharmacokinetics Absorption Phytonadione is readily absorbed following intramuscular administration. Distribution After absorption, phytonadione is initially concentrated in the liver, but the concentration declines rapidly. Very little vitamin K accumulates in tissues. Elimination Little is known about the metabolic fate of vitamin K. Almost no free unmetabolized vitamin K appears in bile or urine.

🧬 Pharmacodynamics 41 words ▾

12.2Pharmacodynamics The action of the aqueous dispersion, when administered intravenously, is generally detectable within an hour or two and hemorrhage is usually controlled within 3 to 6 hours. A normal INR may often be obtained in 12 to 14 hours.

🧪 Nonclinical Toxicology 23 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity, genotoxicity or impairment of fertility have not been conducted with phytonadione.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 20 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of carcinogenicity, genotoxicity or impairment of fertility have not been conducted with phytonadione.

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL - 0.5 mL Ampul Label NDC 0409-9157-31 0.5 mL Single-dose Ampul Rx only VITAMIN K 1 Inj. (Phytonadione Injectable Emulsion, USP) 1 mg/0.5 mL Neonatal Concentration Contains no more than 100 mcg/L of aluminum. Protect from light. Dist. by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA244659 AA#### YYYY-MMM PRINCIPAL DISPLAY PANEL - 0.5 mL Ampul Label

PRINCIPAL DISPLAY PANEL - 0.5 mL Ampul Tray Label 0.5 mL Single-dose Ampul Rx only NDC 0409-9157-50 Contains 5 of NDC 0409-9157-31 VITAMIN K 1 Injection (Phytonadione Injectable Emulsion, USP) 1 mg/0.5 mL Neonatal Concentration Protect from light. Keep ampuls in tray until time of use. For Intramuscular, Subcutaneous, or Intravenous (with caution).

Each mL contains phytonadione 2 mg; polyoxyethylated fatty acid derivative 70 mg; dextrose, hydrous 37.5 mg; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH 6.3 (5.0 to 7.0). DOSAGE: See Prescribing Information.

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc. Lake Forest, IL 60045 USA Hospira PAA244658 PRINCIPAL DISPLAY PANEL - 0.5 mL Ampul Tray Label

PRINCIPAL DISPLAY PANEL - 1 mL Ampul Label NDC 0409-9158-31 1 mL only Single-dose Ampul VITAMIN K 1 Inj. (Phytonadione Injectable Emulsion, USP) 10 mg/mL Contains no more than 110 mcg/L of aluminum. Protect from light. Dist. by Hospira, Inc. Lake Forest, IL 60045 USA Rx only PAA244656 AA#### YYYY-MMM PRINCIPAL DISPLAY PANEL - 1 mL Ampul Label

PRINCIPAL DISPLAY PANEL - 1 mL Ampul Tray Label 1 mL Single-dose Ampul Rx only NDC 0409-9158-50 Contains 5 of NDC 0409-9158-31 VITAMIN K 1 Injection (Phytonadione Injectable Emulsion, USP) 10 mg/mL Protect from light. Keep ampuls in tray until time of use. For Intramuscular, Subcutaneous, or Intravenous (with caution).

Each mL contains phytonadione 10 mg; polyoxyethylated fatty acid derivative 70 mg; dextrose, hydrous 37.5 mg; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH 6.3 (5.0 to 7.0). DOSAGE: See Prescribing Information.

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc. Lake Forest, IL 60045 USA Hospira PAA244655 PRINCIPAL DISPLAY PANEL - 1 mL Ampul Tray Label

PRINCIPAL DISPLAY PANEL - 1 mL Ampul Label - novaplus NDC 0409-9158-11 Rx only 1 mL Single-dose Ampul VITAMIN K 1 Inj. (Phytonadione Injectable Emulsion, USP) 10 mg/mL Contains no more than 110 mcg/L of aluminum. Protect from light. Dist. by Hospira, Inc. Lake Forest, IL 60045 USA novaplus ™ PAA244652 AA#### YYYY-MMM PRINCIPAL DISPLAY PANEL - 1 mL Ampul Label - novaplus

PRINCIPAL DISPLAY PANEL - 1 mL Ampul Tray Label - novaplus 1 mL Single-dose Ampul Rx only NDC 0409-9158-55 Contains 5 of NDC 0409-9158-11 VITAMIN K 1 Injection (Phytonadione Injectable Emulsion, USP) 10 mg/mL For Intramuscular, Subcutaneous, or Intravenous (with caution). Protect from light. Keep ampuls in tray until time of use.

Each mL contains phytonadione 10 mg; polyoxyethylated fatty acid derivative 70 mg; dextrose, hydrous 37.5 mg; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH 6.3 (5.0 to 7.0). DOSAGE: See Prescribing Information.

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc. Lake Forest, IL 60045 USA Novaplus is a registered trademark of Vizient, Inc. PAA244530 novaplus ™ PRINCIPAL DISPLAY PANEL - 1 mL Ampul Tray Label - novaplus

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
1.5K
Units reimbursed last 4 qtrs
7K
Gross reimbursed last 4 qtrs
$352K
Avg / prescription
$227.41
Avg / unit
$50.3575
Latest quarter Q1 2026
413Rx
Fee-for-service vs managed care ⓘ
95% FFS
Fee-for-service · 1,466 Rx Managed care · 82 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 5 units · 0.1 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 1,065 units · 2.7 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 204 units · 4.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 336 units · 5.4 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: no data reported TN North Carolina: no data reported 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: 5,381 units · 105 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.1105
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 Alabama 105 /100k
2 Maryland 5.4 /100k
3 Kentucky 4.5 /100k
4 California 2.7 /100k
5 Washington 0.1 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
5 ampules this page00409-9158-01 1,548 Rx · $352,025
5 ampules00409-9158-25 No Medicaid data
Drug total (last 4 qtrs): 1,548 Rx · 6,991 units · $352,025 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
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 Hospira, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 5 ampules (00409-9158-25). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Hospira, Inc. 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 J3430 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.
← 00409-9157-01 · Hospira, 00409-9558-49 · Hospira, →
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.