NDC 00404-9935-05 — PHYTONADIONE 1 mg/.5mL, 1 syringe

🆔 Identity & classification

FDA NDC (as labeled) 0404-9935-05

Product NDC 0404-9935

11-digit billing NDC 00404993505

RxCUI 727625

UNII A034SE7857

Application # ANDA083722

SPL Set ID 0d971993-466c-46dd-bdd6-2e300173621e

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 2022-01-13

Route PARENTERAL

Dosage form INJECTION, EMULSION

Substance PHYTONADIONE

TE code (Orange Book) AB1 · RLD · RS

Why two NDCs? The FDA registers this code as 0404-9935-05 — 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 → 00404-9935-05. 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.

🏭 Manufacturer & labeler

LabelerHenry Schein, Inc.

Application holderINTERNATIONAL MEDICATION SYSTEM

FDA applicationANDA083722 (ANDA)

Labeler code00404

First marketedJan 2022

Product typeHuman Prescription Drug

Portfolio171 products on file

🔎 All NDCs from Henry Schein, Inc.

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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist

Phytonadione is simply vitamin K1 — the same vitamin K your body uses to make clotting proteins in the liver. Your doctor has prescribed it because your blood isn't clotting proper...
What exactly is phytonadione, and why has my doctor prescribed it?
Phytonadione is not instant. If you're receiving it by injection into a vein, you may start to see improvement in your clotting levels within one to two hours, and bleeding is usua...
Yes — and this is important to understand. Phytonadione directly counteracts warfarin's blood-thinning effect, which is exactly why it's used when your INR is dangerously high. How...

📖 Read our full Phytonadione guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.

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.

💲 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	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
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)0404-9935-05

11-digit billing NDC00404-9935-05

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 / pkg1 units

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Phytonadione 1 mg/.5mLthis 00404-9935-05	Henry	1 syringe	—	AB1	FDA listed	—
Phytonadione 1 mg/.5mL 25021-0505-70	Sagent	10 syringes	—	AB1	FDA listed	—
Phytonadione 1 mg/.5mL 46708-0826-05	Alembic	1 syringe	—	AB1	FDA listed	—
Phytonadione 1 mg/.5mL 62332-0826-05	Alembic	1 syringe	—	AB1	FDA listed	—
Phytonadione 1 mg/.5mL 69097-0003-96	Cipla	10 syringes	—	AB1	FDA listed	—
Phytonadione 1 mg/.5mL 70095-0154-02	Sun	1 syringe	—	AB1	FDA listed	—
phytonadione 1 mg/.5mL 70121-1682-07	Amneal	1 syringe	—	AB1	FDA listed	—
Phytonadione 1 mg/.5mL 76329-1240-01	International	1 syringe	—	AB1	FDA listed	—
Phytonadione 1 mg/.5mL 81607-0020-02	Orbicular	1 syringe	—	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

🏛️

2022

On the market since

Jan 2022

📍

2026

Currently FDA-listed

4 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00404-9935-05 You're viewing this	1 BOX in 1 BAG (0404-9935-05) / 1 SYRINGE in 1 BOX / .5 mL in 1 SYRINGE	2022-01-13	Active

🧭 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)	— 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)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“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 FDA registers it as 0404-9935-05, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00404-9935-05, written without dashes as 00404993505. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 00404-9935-05, the first segment (00404) is the labeler code FDA assigned to Henry Schein, Inc.; the middle segment (9935) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Henry Schein, Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Henry Schein, 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.

📄 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.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description

🚨 Boxed Warning 69 words ▾

BOXED WARNING WARNING – HYPERSENSITIVITY REACTIONS WITH INTRAVENOUS AND INTRAMUSCULAR USE Fatal hypersensitivity reactions, including anaphylaxis, have occurred during and immediately after intravenous and intramuscular injection of Phytonadione Injectable Emulsion. 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 WARNING AND PRECAUTIONS(5.1)].

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE

1.1Treatment of Hypoprothrombinemia Due to Vitamin K Deficiency or Interference Phytonadione Injectable Emulsion, USP 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 Phytonadione Injectable Emulsion, USP is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates. Phytonadione Injectable Emulsion, USP 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 cause 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)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION

2.1Dosing Considerations Whenever possible, administer Phytonadione Injectable Emulsion, USP 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 dose of Phytonadione Injectable Emulsion, USP. The coagulant effects of Phytonadione Injectable Emulsion, USP are not immediate; improvement of INR may take 1-8 hours. Interim use of whole blood or component therapy may also be necessary if bleeding is severe.

When Phytonadione Injectable Emulsion 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. Phytonadione Injectable Emulsion is not a clotting agent, but overzealous therapy with Phytonadione Injectable Emulsion 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 Phytonadione Injectable Emulsion 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 : Phytonadione Injectable Emulsion 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 Phytonadione Injectable Emulsion are not warranted in liver disease if the initial response is unsatisfactory. Failure to respond to Phytonadione Injectable Emulsion may indicate that the condition being treated is inherently unresponsive to Phytonadione Injectable Emulsion.

Hyppoprothrombinemia Due to Other Causes (Non-Anticoagulation-Induced Hypoprothrombinemia : Phytonadione Injectable Emulsion 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 6-8 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 Phytonadione Injectable Emulsion 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 Phytonadione Injectable Emulsion 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 Phytonadione Injectable Emulsion with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. When diluted, start administration of Phytonadione Injectable Emulsion immediately after dilution. Discard unused portions of diluted solution as well as unused contents of the vial.

Protect Phytonadione Injectable Emulsion from light at all times. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Administer Phytonadione Injectable Emulsion, USP by the subcutaneous route, whenever possible.

(2.1) When intravenous administration is unavoidable, inject the drug very slowly, not exceeding 1 m…

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1 mg/0.5 mL single-dose vial and a SAF-T-Jet vial injector. Injection: 1 mg/0.5 mL single-dose vial and a SAF-T-Jet vial injector. (3)

⛔ Contraindications 25 words ▾

4 CONTRAINDICATIONS Hypersensitivity to phytonadione or any other component of this medication [see WARNING AND PRECAUTIONS (5.1)]. Hypersensitivity to any component of this medication. (4)

⚠️ Warnings and Cautions 154 words ▾

5 WARNINGS AND PRECAUTIONS

5.1Hypersensitivity Reactions Fatal and severe hypersensitivity reactions, including anaphylaxis, have occurred with intravenous or intramuscular administration of Phytonadione Injectable Emulsion. 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 Phytonadione Injectable Emulsion 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)].

5.3Cutaneous Reactions Parenteral administration of vitamin K replacements (including Phytonadione Injectable Emulsion) 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 Phytonadione Injectable Emulsion for skin reactions and institute medical management. Cutaneous Reactions: May occur with parenteral use. Discontinue drug and manage medically.

(5.3)

🤒 Adverse Reactions 204 words ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Hypersensitivity Reactions [see WARNING AND PRECAUTIONS (5.1)] • Cutaneous Reactions [see WARNING AND PRECAUTIONS (5.3)]

6.1Clinical Trials and Post-Marketing 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. The following adverse reactions have been identified during post-apporval use of Phytonadione Injectable Emulsion. 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. Most common adverse reactions are cyanosis, diaphoresis, dizziness, dysgeusia, dyspnea, flushing, hypotension and tachycardia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 76 words ▾

7 DRUG INTERACTIONS Anticoagulants Phytonadione Injectable Emulsion may induce temporary resistance to prothrombin-depressing anticoagulants, especially when larger doses of Phytonadione Injectable Emulsion 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). Phytonadione Injectable Emulsion does not affect the anticoagulant action of heparin.

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

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary 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 If available, preservative-free Phytonadione is recommended when Phytonadione is needed during lactation [see USE IN SPECIFIC POPULATION (8.4)]. Phytonadione is present in breastmilk. There are no data on the effects of Phytonadione Injectable Emulsion on the breastfed child or on milk production.

The developmental and health benefits of breastfeeding should be considered along with the clinical need for Phytonadione Injectable Emulsion and any potential adverse effects on the breastfed child from Phytonadione Injectable Emulsion or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Phytonadione Injectable Emulsion 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. Pregnancy: If available, use the preservative-free formulation in pregnant women.

(8.1) Lactation: If available, use the preservative-free formulation in lactating women. (8.2) Pediatric Use: The safety and effectiveness of Phytonadione Injectable Emulsion in pediatric patients from 6 months from 17 years have not been established. (8.4) See 17 for PATIENT COUNSELING INFORMATION.

08/2023

🆘 Overdosage 19 words ▾

10 OVERDOSAGE Hemolysis, jaundice, and hyperbilirubinemia in newborns, particuarly in premature infants, may result from Phytonadione Injectable Emulsion overdose.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINCIAL PHARMACOLOGY

12.1Mechanism of Action Phytonadione Injectable Emulsion aqueous colloidal solution 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.

📦 How Supplied / Storage and Handling 165 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phytonadione Injectable Emulsion, USP is a yellow, sterile, aqueous colloidal solution and is supplied in unit use packages containing one single-dose vial and a SAF-T-Jet® vial injector, 27 G. x ½ needle. Phytonadione Injectable Emulsion USP, 1 mg in 0.5 mL Stock No. 1240 NDC 76329-1240-1 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect Phytonadione Injectable Emulsion, USP from light. Store container in closed original carton until contents have been used. Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 76329-1240-1 10 individual cartons shrink wrapped as a group of 10 cartons NDC 0404-9935-05 1 unit use package containing one single-dose vial and a SAF-T-Jet® vial injector in a bag (Vial bears NDC 76329-1240-1) 1 mg in 0.5 mL Image1.jpg

📋 Description 159 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 C31H46O2 and its molecular structure is: Phytonadione Injectable Emulsion, USP injection is a yellow, sterile, aqueous colloidal solution of vitamin K 1 , with a pH of 3.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione Injectable Emulsion, USP is available in 1 mg (1 mg/0.5 mL) single-dose vials.

Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains the following inactive ingredients: 10 mg polysorbate 80, 10.4 mg propylene glycol, 0.17 mg sodium acetate anhydrous, and 0.00002 mL glacial acetic acid. Additional glacial acetic acid or sodium acetate anhydrous may have been added to adjust pH to meet USP limits of 3.5 to 7.0. Formula1.jpg

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

colitis: Swelling and irritation of the inner lining of the large intestine, or colon.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

diaphoresis: Heavy or excessive sweating.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dysgeusia: A changed or unpleasant sense of taste, such as a metallic taste.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

hemolysis: The breaking apart of red blood cells, which can lower the number of cells available to carry oxygen.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperbilirubinemia: A higher-than-normal level of bilirubin in the blood, which can cause yellowing of the skin or eyes.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

infusion: Slowly delivering fluid or medicine into a vein over a period of time, usually through a drip.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

intramuscular: An injection given deep into a muscle; often written as IM.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

prophylaxis: Treatment given to prevent an infection or illness before it starts, rather than to treat one that is already present.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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