Cyanocobalamin Injection, Solution
NDC Package 69680-113-99

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Cyanocobalamin injection is cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:Addisonian (pernicious) anemiaGastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomyFish tapeworm infestationMalignancy of pancreas or bowelFolic acid deficiencyIt may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. This formulation utilizes a injection, solution delivery system. Marketed by Vitruvias Therapeutics, this product is identified by NDC 69680-113 and is authorized under FDA application ANDA209255.

Identification & Billing

NDC Package Code
69680-113-99
Package Description
10 VIAL, MULTI-DOSE in 1 BOX / 10 mL in 1 VIAL, MULTI-DOSE (69680-113-10)
Product Code
69680-113
11-Digit Billing Format
69680011399
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyanocobalamin
Non-Proprietary Name
Cyanocobalamin
Substance Name
Cyanocobalamin
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intramuscular - Administration within a muscle.
Active Ingredient(s)
CYANOCOBALAMIN 1000 ug/mL
Pharmacologic Class
Usage Information
Cyanocobalamin is indicated for vitamin B12 deficiencies due to malabsorption which may be associated with the following conditions:Addisonian (pernicious) anemiaGastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomyFish tapeworm infestationMalignancy of pancreas or bowelFolic acid deficiencyIt may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin.Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation.Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).

Regulatory & Marketing

Labeler Name
Vitruvias Therapeutics
Product Type
Human Prescription Drug
FDA Application #
ANDA209255
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-02-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J3420
Source: ASP
Vitamin b12 injection
HCPCS Dosage 1000 MCG
Units / Pkg 100

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69680-113-99 identifies a specific commercial package of 10 vial, multi-dose in 1 box / 10 ml in 1 vial, multi-dose (69680-113-10) of Cyanocobalamin, a human prescription drug labeled by Vitruvias Therapeutics. This injection, solution is formulated for intramuscular use and contains cyanocobalamin as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Vitruvias Therapeutics on January 02, 2019. The current certification is valid through December 31, 2026.

How is this Vitruvias Therapeutics product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69680011399. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69680-113-99
11-Digit CMS (5-4-2)
69680-0113-99

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.