Cyanocobalamin Injection, Solution
NDC Package 55150-364-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    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) anemia • Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy • Fish tapeworm infestation • Malignancy of pancreas or bowel • Folic acid deficiency It 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 Auromedics Pharma Llc, this product is identified by NDC 55150-364 and is authorized under FDA application ANDA213874.

Identification & Billing

NDC Package Code
55150-364-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE
Product Code
55150-364
11-Digit Billing Format
55150036401
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) anemia • Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy • Fish tapeworm infestation • Malignancy of pancreas or bowel • Folic acid deficiency It 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 is also suitable for the vitamin B12 absorption test (Schilling test).

Regulatory & Marketing

Labeler Name
Auromedics Pharma Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA213874
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-08-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (55150-364). Click a package code to view its specific billing and regulatory data.

55150-364-10
10 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE
55150-364-25
25 VIAL, MULTI-DOSE in 1 CARTON / 1 mL in 1 VIAL, MULTI-DOSE

* 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 55150-364-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 1 ml in 1 vial, multi-dose of Cyanocobalamin, a human prescription drug labeled by Auromedics Pharma Llc. 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 Auromedics Pharma Llc on December 08, 2020. The current certification is valid through December 31, 2026.

How is this Auromedics Pharma Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55150036401. 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)
55150-364-01
11-Digit CMS (5-4-2)
55150-0364-01

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