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Phytonadione 10 mg/mL Injection, Emulsion, 10 vials — NDC 69097-0708-96 package photo
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Phytonadione 10 mg/mL Injection, Emulsion, 10 vials — NDC 69097-708-96 (Billing 69097-0708-96)

by Cipla USA Inc. · 10 VIAL in 1 CARTON / 1 mL in 1 VIAL

This is a package of 10 vials of Phytonadione 10 mg/mL Injection, Emulsion from Cipla USA Inc., marketed since Apr 2022 and currently FDA-listed. It is this product's only package size.

NDC 69097-0708-96
🏷️ FDA NDC (as labeled) 69097-708-96 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

🚨
Active recall for this product.
Class II · Oct 31, 2025 — Failed Stability Specifications: Observed OOS results: eg results for colour index (Cipla Limited) · FDA recall D-0197-2026
Lots / codes: Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025 · reported Dec 10, 2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69097-708-96
Product NDC 69097-708
11-digit billing NDC 69097070896
NCPDP billing unit ML — per mL (volume)
RxCUI 312424, 1670192
UNII A034SE7857
Application # ANDA214596
SPL Set ID 1add4de5-0f9c-453e-9dd5-abb8077b566a
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 2022-04-27
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, EMULSION
Substance PHYTONADIONE

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

GPI-14 77204030002010
GPI class Phytonadione
GCN Seq No 002304
GCN 94726
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 PHYTONADIONE 10 MG/ML VIAL
FDB brand name Phytonadione
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 002304
  • GCN: 94726
  • GPI-14 (Medi-Span): 77204030002010
  • HICL (First Databank): 001040
  • AHFS class code: 88:24.00.00
  • RxCUI (RxNorm): 312424
Why two NDCs? The FDA registers this code as 69097-708-96 — 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 → 69097-0708-96. 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 PHYTONADIONE 10 MG/ML VIAL 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 $61.53 $615.30 / 10 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)69097-708-96
11-digit billing NDC69097-0708-96
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3430
DescriptorInjection, phytonadione (vitamin k), per 1 mg
Billing units / pkg100 units
How the units are derivedThis package is 1; the HCPCS unit is 1 MG, so one package = 100 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
69097-0708-96 You're viewing this Main listing 10 VIAL in 1 CARTON / 1 mL in 1 VIAL 2022-04-27 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phytonadione 10 mg/mL 00404-9969-01 Henry 1 ampule — AB1 FDA listed —
Vitamin K1 10 mg/mL 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/mLthis 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

🏛️
2022
On the market since
Apr 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.

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.

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

  • UNII Q40Q9N063P
    Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
  • UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII LX22YL083G
    A simple sugar derived from corn or other sources. It acts as a filler to give the medicine bulk and volume, and as a sweetener to improve taste in oral medications.
  • UNII 6D4M1DAL6O
    Polyoxyl 35 castor oil is a synthetic compound made by chemically treating castor oil. It works as a solubilizer and emulsifier to help dissolve and evenly mix oily and water-based ingredients in medicines.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

5 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

LabelerCipla USA Inc.
Application holderCIPLA LTD
FDA applicationANDA214596 (ANDA)
Labeler code69097
First marketedApr 2022
Product typeHuman Prescription Drug
Portfolio222 products on file
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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 142 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 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 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 phytonadione injectable emulsion. 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 Phytonadione injectable emulsion 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 is it definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.

( 1.1 ) Phytonadione injectable emulsion 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 Phytonadione injectable emulsion 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 is indicated for prophylaxis and treatment of vitamin K-deficiency bleeding in neonates.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer phytonadione injectable emulsion 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 phytonadione injectable emulsion 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 phytonadione injectable emulsion. The coagulant effects of phytonadione injectable emulsion 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.

Whenever possible, administer benzyl alcohol-free formulations in pediatric patients [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.4 )] . 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 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.

Hypoprothrombinemia 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. 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 ) and Use in Specific Populations ( 8.4 )] . When diluted, start administration of… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 24 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 2 mg/mL and 10 mg/mL single-dose vials. Injection: 2 mg/mL and 10 mg/mL single-dose vials. ( 3 )

⛔ Contraindications 30 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 ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative: Use benzyl alcohol-free formulations in neonates and infants, if available. ( 5.1 ) 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 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 )] .

5.2Risk of Serious Adverse Reaction in Infants due to Benzyl Alcohol Preservative Use benzyl alcohol-free 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 phytonadione injectable emulsion. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations.

When prescribing phytonadione injectable emulsion in infants, consider the combined daily metabolic load of benzyl alcohol from all sources including phytonadione injectable emulsion (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 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.

🤒 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 Cipla Ltd at 1-866-604-3268 , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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-approval 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.

🔄 Drug Interactions 78 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 ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS 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 to 17 years have not been established. ( 8.4 )

8.1Pregnancy Risk Summary Phytonadione injectable emulsion 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 phytonadione injectable emulsion is needed during pregnancy, consider using a benzyl alcohol-free 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 Phytonadione injectable emulsion contains benzyl alcohol. If available, preservative-free phytonadione injectable emulsion is recommended when phytonadione injectable emulsion 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 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. 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 produc… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage 19 words ▾

10 OVERDOSAGE Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may result from phytonadione injectable emulsion overdose.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL 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 93 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phytonadione injectable emulsion, USP is a clear yellow, sterile, aqueous colloidal solution and is supplied in a package of 10 as follows: NDC No. Container Amount of Phytonadione injectable emulsion In Container Volume Concentration 69097-709-96 10 single-dose vials per carton 1 mg 0.5 mL 2 mg/mL 69097-708-96 10 single-dose vials per carton 10 mg 1 mL 10 mg/mL Store at 20° to 25°C (68° to 77°F); [see USP Controlled Room Temperature]. Protect phytonadione injectable emulsion from light.

Store container in closed original carton until contents have been used.

📋 Description 160 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: Phytonadione injectable emulsion, USP is a clear yellow, sterile, aqueous colloidal solution of vitamin K 1 , with a pH of 4.5 to 7.0, available for injection by the intravenous, intramuscular, and subcutaneous routes. Phytonadione injectable emulsion, USP is available in 1 mg (2 mg/mL) and 10 mg (10 mg/mL) single-dose vials.

Each milliliter of phytonadione injectable emulsion, USP contains the following inactive ingredients: 70 mg polyoxyl 35 castor oil, 37.5 mg dextrose monohydrate, 9 mg benzyl alcohol (preservative), and water for injection. Phytonadione injectable emulsion, USP contains glacial acetic acid for pH adjustment to 6.3 (4.5 – 7.0). structure

💬 Information for Patients 157 words ▾

17 PATIENT COUNSELING INFORMATION Inform the patient of the following important risks of phytonadione injectable emulsion: Serious Hypersensitivity Reactions Advise the patient and caregivers to immediately report signs of hypersensitivity after receiving phytonadione injectable emulsion [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 phytonadione injectable emulsion) 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 phytonadione injectable emulsion. These reactions may be delayed for up to a year after treatment [see Warnings and Precautions ( 5.3 )] . Manufactured by: Cipla Ltd., India At M/s Immacule Lifesciences Pvt.

Ltd. India Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059 Revised: 3 /2022

🧪 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 143 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 69097-709-30 RX Only Phytonadione Injectable Emulsion, USP 1 mg/0.5 mL Neonatal Concentration 0.5 mL Single-Dose Vial Contains no more than 500 mcg/L of aluminum. Protect from Light. Cipla NDC 69097-708-31 RX Only Phytonadione Injectable Emulsion, USP10 mg/ mL 1 mL Single-Dose Vial Contains no more than 500 mcg/L of aluminum.

Protect from Light. Cipla NDC 69097-709-96 RX Only Phytonadione Injectable Emulsion, USP 1 mg/0.5 mL Neonatal Concentration For INTRAMUSCULAR, SUBCUTANEOUS or INTRAVENOUS (with caution). Protect from light.

Keep vials in carton until time of use. 10 X 0.5 mL vials per carton Single-Dose Vials Cipla NDC 69097-708-96 RX Only Phytonadione Injectable Emulsion, USP 10 mg/ mL For INTRAMUSCULAR, SUBCUTANEOUS or INTRAVENOUS (with caution). Protect from light.

Keep vials in carton until time of use. 10 X 1 mL vials per carton Single-Dose Vials Cipla containerlabel1mgper0pt5ml contaner-label-10mg carton-label-1mg carton-labels-10mg

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 – Q4 2025 · 4 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
41
Units reimbursed last 4 qtrs
22
Gross reimbursed last 4 qtrs
$1.4K
Avg / prescription
$33.02
Avg / unit
$62.5247
Latest quarter Q4 2025
28Rx
Fee-for-service vs managed care ⓘ
100% FFS
Fee-for-service · 41 Rx Managed care · 0 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported 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: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 22 units · 0.4 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: no data reported 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
0.40.4
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 0.4 /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.

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) ✓ 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 Cipla USA Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Cipla USA 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.
← 69097-0686-34 · Cipla 69097-0709-96 · Cipla →
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.