What is the NDC for Vitamin K?

January 5, 2026 •

4 min read

The National Drug Code (NDC) is a unique, three-segment number assigned to every human drug product marketed in the United States, as required by the FDA. While 'vitamin K' is a broad term, the prescription form of vitamin K, phytonadione, has specific NDC numbers associated with its various manufacturers and formulations.

Quick Summary

The National Drug Code (NDC) for vitamin K, specifically the prescription drug phytonadione, is not a single code but a series of codes dependent on the manufacturer, dosage, and packaging. It serves as a universal identifier in the US healthcare system for accurate tracking, billing, and ensuring the right product is dispensed to patients.

Key Points

NDC is Product-Specific: The National Drug Code (NDC) for vitamin K varies and is not a single number; it depends on the manufacturer, dosage, and package type of the prescription drug, phytonadione.
Not for Supplements: Over-the-counter vitamin K dietary supplements do not use NDCs, which are reserved for drugs regulated by the FDA.
Code Segments: An NDC is a three-segment number identifying the labeler (manufacturer), product (formulation and strength), and package size.
Billing and Tracking: The correct NDC is critical for accurate insurance billing, pharmacy claims, and efficient tracking within the healthcare supply chain.
Patient Safety: Proper identification of a drug via its NDC helps prevent medication errors and ensures the right product is dispensed to the patient.
Sources for Lookup: To find a specific NDC, one should refer to the product packaging or search official databases like the FDA's NDC Directory and DailyMed.
Example NDCs: Specific NDCs exist for phytonadione, such as NDC 0409-9157 for certain injections and NDC 60687-381 for certain tablets.

Understanding the NDC System for Pharmaceuticals

The National Drug Code (NDC) is more than just a number; it's a critical component of the American healthcare system designed to ensure precision and safety in medication management. It is a unique 10-digit or 11-digit number consisting of three distinct segments. Each segment identifies a specific piece of information about the drug product:

Labeler Code: Assigned by the FDA, this first segment identifies the manufacturer, repackager, or distributor.
Product Code: This segment identifies the specific strength, dosage form (e.g., tablet, injection), and formulation.
Package Code: This final segment identifies the specific package size and type.

For a general nutrient like 'vitamin K', which is also available in non-prescription supplements, there is no single NDC. However, the prescription drug form, phytonadione (vitamin K1), is assigned a specific set of NDCs. This is crucial for distinguishing between over-the-counter vitamins and regulated prescription medications.

The NDC for Prescription Vitamin K (Phytonadione)

Because different companies manufacture phytonadione in various dosages and forms, multiple NDC numbers exist. For example, injectable phytonadione from one manufacturer will have a different NDC than a tablet version from another. Looking up a specific NDC number is essential for accuracy in pharmacy dispensing and insurance billing. Some examples of NDC codes associated with phytonadione include:

NDC 0409-9157: An injectable emulsion of phytonadione, often distributed in ampules.
NDC 60687-381: A 5 mg phytonadione tablet, packaged for unit-dose dispensing.

These examples illustrate that the NDC is not tied to the generic name 'phytonadione' alone but to the precise product sold by a specific labeler. To find the exact NDC for a medication, one must reference the product's packaging or search the FDA's NDC Directory, accessible via resources like DailyMed.

Importance of Accurate NDC Information

Billing and Reimbursement: Insurers and payment processors rely on accurate NDC information to process claims. Incorrect NDCs can lead to claim rejections and delays.
Supply Chain Management: NDCs enable efficient inventory tracking and management for pharmacies and distributors.
Patient Safety: Using the correct NDC helps ensure that patients receive the right medication, dosage, and form, minimizing the risk of medication errors.
Regulatory Compliance: The FDA monitors drug products via the NDC system, which is crucial for tracking recalls and ensuring compliance.

Comparing Vitamin K Forms: Prescription vs. Supplement


Feature	Prescription Vitamin K (Phytonadione)	Dietary Vitamin K Supplement
Primary Use	Treat coagulation disorders, reverse anticoagulant effects, prevent neonatal bleeding.	Promote bone health and cardiovascular health.
Form(s)	Injectable emulsion (IV, IM, SC), oral tablets.	Oral capsules, tablets, liquids, and gummies, often combined with other vitamins.
Regulation	Regulated by the FDA as a human prescription drug, assigned specific NDCs.	Regulated as a dietary supplement, not required to have an NDC.
Dose	Precise, medically determined doses (e.g., 5 mg, 10 mg), often higher than RDA.	Varied dosages (e.g., 100 mcg, 300 mcg).
Administration	Requires administration by a healthcare provider for injections; oral forms need a prescription.	Self-administered by the consumer.
Risk	Lower risk of anaphylactic reaction with IV use, but requires caution; high doses can cause warfarin resistance.	Generally safe at recommended doses, but potential interactions with medications like warfarin exist.
Example NDC	0409-9157 (for injection, from Hospira).	Not applicable, as dietary supplements do not use NDCs.

The Role of the Labeler in Determining the NDC

The National Drug Code is not assigned to the active ingredient, but to the final, commercial product. This means that if multiple manufacturers sell a 5 mg phytonadione tablet, each company's product will have a unique NDC. This practice ensures that the supply chain is transparent and that accountability is maintained at every level, from production to patient delivery. The FDA updates its NDC Directory daily, and manufacturers are responsible for submitting accurate and current information via Structured Product Labeling (SPL) files. For a specific product and package, the NDC is a static identifier. However, the overall list of NDCs for "vitamin K" changes as products enter and leave the market or as manufacturers change their packaging and formulations.

Conclusion

There is no single NDC for vitamin K, as the code is assigned to specific, finished drug products rather than the general nutrient. The NDC for prescription vitamin K (phytonadione) is dependent on the manufacturer, dosage, and package size, and can be found by consulting the product label or the FDA's DailyMed database. This unique identifier system is foundational for medication safety, accurate billing, and robust supply chain management in the United States. Whether used in a clinical setting to correct a coagulation disorder or in a supplement for dietary support, understanding the distinction and identification system is vital for all involved.

For further information on drug identification, the FDA's NDC Directory is the authoritative source.

Frequently Asked Questions

There is no single NDC for vitamin K because the NDC is a product-specific identifier. It is assigned to the final, packaged drug product by the manufacturer, not to the generic substance itself. Therefore, different companies producing vitamin K (as phytonadione) in different forms and strengths will each have their own unique NDCs.

The most reliable way to find the correct NDC is to look at the medication's packaging or label. You can also use reputable online databases, such as the FDA's NDC Directory or DailyMed, by searching for the medication's name or active ingredient (phytonadione).

No, dietary vitamin K supplements do not have NDCs. The NDC system is used for drugs, while supplements are regulated differently by the FDA. The codes are reserved for prescription and over-the-counter medications.

Phytonadione is a specific form of vitamin K, known as vitamin K1, that is commonly used as a prescription medication to address coagulation disorders. 'Vitamin K' is a broader term that includes various forms, such as K1 and K2 (menaquinones), found in foods and supplements.

An NDC is a three-part code that provides crucial information about a drug product. The first segment identifies the labeler (manufacturer), the second identifies the product (strength, form), and the third identifies the package size and type.

An example of an NDC for a vitamin K1 injectable emulsion is 0409-9157, manufactured by Hospira. Note that this specific NDC may apply to a particular dosage and package size and is subject to change based on marketing status.

No, the assignment of an NDC code does not necessarily imply FDA approval of a product. The FDA emphasizes that the NDC system is an identification and listing system, and that some unapproved drugs or compounded products may have NDCs.