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phytonadione 1 mg/.5mL Injection, Emulsion — NDC 70121-1682-07 package photo

phytonadione 1 mg/.5mL Injection, Emulsion

by Amneal Pharmaceuticals LLC · 10 TRAY in 1 CARTON (70121-1682-7) / 1 SYRINGE, GLASS in 1 TRAY (70121-1682-1) / .5 mL in 1 SYRINGE, GLASS
NDC 70121-1682-07
🏷️ FDA NDC (as labeled) 70121-1682-7 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

⚠️
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

FDA NDC (as labeled) 70121-1682-7
Product NDC 70121-1682
11-digit billing NDC 70121168207
NCPDP billing unit ML — per mL (volume)
RxCUI 727625
UNII A034SE7857
UPC 0370121168218
Application # ANDA216601
SPL Set ID 2ce1dd90-11ad-4f74-af16-45b7e59f05da
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 2025-11-04
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, EMULSION
Substance PHYTONADIONE
GPI-14 77204030002005
GCN Seq No 002303
GCN 94721
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 1 MG/0.5 ML SYR
FDB brand name Phytonadione
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB1 · RLD · RS
Why two NDCs? The FDA registers this code as 70121-1682-7 — a 5-4-1 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 package segment → 70121-1682-07. 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

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL EU LTD
FDA applicationANDA216601 (ANDA)
Labeler code70121
First marketedNov 2025
Product typeHuman Prescription Drug
Portfolio472 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.

🩺 Clinical

Label name PHYTONADIONE 1 MG/0.5 ML SYR Ingredient Phytonadione (Vit K1)
📗 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 →

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.

💡 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII NVG71ZZ7P0
    A salt derived from acetic acid, sodium acetate anhydrous is used in medicines as a buffer to help maintain stable pH levels and sometimes as a preservative or bulking agent in solid formulations.
  • 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.

💲 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 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)70121-1682-7
11-digit billing NDC70121-1682-07
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ3430
DescriptorInjection, phytonadione (vitamin k), per 1 mg
Billing units / pkg10 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phytonadione 1 mg/.5mL 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/.5mLthis 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 —
Phytonadione 1 mg/.5mL 69097-0709-96 Cipla 10 vials — AB2 FDA listed —
Phytonadione 1 mg/.5mL 43066-0132-10 Baxter 10 vials — AB2 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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 NDCDescription Marketing startStatus
70121-1682-07 You're viewing this 10 TRAY in 1 CARTON (70121-1682-7) / 1 SYRINGE, GLASS in 1 TRAY (70121-1682-1) / .5 mL in 1 SYRINGE, GLASS 2025-11-04 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 ✓ 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 ✓ 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 70121-1682-7, 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: 70121-1682-07, written without dashes as 70121168207. 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 70121-1682-07, the first segment (70121) is the labeler code FDA assigned to Amneal Pharmaceuticals LLC; the middle segment (1682) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code 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 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 147 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 it is 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 hour to 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 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 hours 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 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 hours to 4 hours) may indicate another diagnosis or coagulation disorder.

2.4Directions for Dilution CAUTION: The syringe may not be compatible with Luer-activated valve (LAV) connectors that have internal pin designs, such as LAVs with CLAVE design. 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 syringe. Protect phytonadione injectable emulsion from light at all…

💊 Dosage Forms and Strengths 28 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1 mg/0.5 mL in a single-dose Pre-Filled Glass Syringe. Injection: 1 mg/0.5 mL in a single-dose Pre-Filled Glass Syringe. ( 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 158 words ▾

5 WARNINGS AND PRECAUTIONS 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) ] .

5.3Cutaneous 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 205 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 Amneal Pharmaceuticals LLC at 1-877-835-5472 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 ~2 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 If phytonadione is needed during pregnancy, consider using a preservative-free formulation. 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% to 4% and 15% to 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 injectable emulsion is recommended when phytonadione injectable emulsion is needed during lactation [see 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.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary If phytonadione is needed during pregnancy, consider using a preservative-free formulation. 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% to 4% and 15% to 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 42 words ▾

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.

🆘 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 hours to 6 hours. A normal INR may often be obtained in 12 hours 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 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.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL is available as clear yellow color, solution filled in prefilled glass syringe with SRC tip cap, assembled with grey plunger stopper and natural plunger rod. It is supplied in carton containing ten plastic trays, each having one single-dose prefilled glass syringes and one, SurGuard ® 3 safety hypodermic 27 G. x 1/2” needle with the following presentations: Unit of Sale Strength Each NDC 70121-1682-7 (Carton of 10) 1 mg/0.5 mL NDC 70121-1682-1 (0.5 mL prefilled syringe) Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect phytonadione injectable emulsion from light. Store container in closed original carton until contents have been used. Syringe Assembly Directions: See User Guide USE ASEPTIC TECHNIQUE Do not remove from carton or assemble until ready to use.

CAUTION: The syringe may not be compatible with Luer-activated valve (LAV) connectors that have internal pin designs, such as LAVs with CLAVE design. 1. Remove the prefilled syringe cap by unscrewing it counter-clockwise (see Figure A) .

Figure A 2. Open the needle package by using both thumbs to pull apart the packaging (see Figure B) . Remove the needle from the package.

Figure B 3. Attach the needle with the needle cap to the syringe by turning clockwise until it cannot twist any further (see Figure C) . Do not remove the needle cap.

Figure C Pull back the needle safety shield (see Figure D) . Figure D 4. Carefully remove needle cap from the needle by pulling straight off (see Figure E) and throw it away in a sharp disposal container.

Make sure the needle does not touch anything before the injection. Figure E 5. Hold the syringe at eye level with the needle pointing upwards.

Check to see air bubble. Remove it by tapping the side of the syringe with your finger until it rise towards the tip (see Figure F) . Then, slowly push the plunger up until a small amount of liquid drips from the needle (see Figure G) .

Figure F Figure G 6. After injection, position shield in preparation for device activation: Using a one-handed technique, push the tab forward with your finger or thumb so that the shield is less than 90 degrees from the needle (see Figure H) . NOTE: Keep your finger or thumb behind the tab at all times.

Figure H 7. Activate shield: Position the shield approximately 45 degrees to flat surface. Press down with a GENTLE, QUICK, MOTION until a distinct AUDIBLE CLICK is heard (see Figure I) .

Note: Audible click may not be heard on small needle sizes: visual confirmation is required. Figure I 8. VISUALLY CONFIRM that needle is fully engaged under lock (see Figure J) .

Figure J 9. Following activation of the needle shield, immediately discard the unit into an approved sharps container. CAUTION: LIQUID IN GLASS.

HANDLE WITH CARE. INSPECT SYRINGE FOR DAMAGE PRIOR TO ASSEMBLY. 01 02 03 04 05 06 07 08 09 10

📋 Description 181 words ▾

11 DESCRIPTION Phytonadione, USP is a vitamin K replacement, which is a clear, yellow to amber, very viscous liquid. It is soluble in dehydrated alcohol, in benzene, in chloroform, in ether and in vegetable oils; slightly soluble in alcohol and insoluble in water. It has a molecular weight of 450.70 g/mol.

Phytonadione is 2-Methyl-3-(3,7,11,15-tetramethylhexadec-2-en-1-yl)naphthalene-1,4-dione. Its molecular formula is C 31 H 46 O 2 and its molecular structure is: Phytonadione Injectable Emulsion, USP is a sterile, clear yellow color 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 prefilled glass syringe.

Each 0.5 mL of Phytonadione Injectable Emulsion, USP contains: Active: Phytonadione, USP (Vitamin K1)………………1 mg Inactive: Polysorbate 80 …………………………10 mg Propylene glycol ………………………10.4 mg Sodium acetate anhydrous.…………..…0.17 mg Glacial acetic acid .………….….….......0.00002 mL Water for injection.….…………………q.s. to 0.5 mL 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. 1

💬 Information for Patients 98 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) ]. 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: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

11-2025-03

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70121-1680-07 · Amneal 70121-1685-01 · Amneal →
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.