Cyanocobalamin Spray
NDC Package 45802-491-84

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

Package Information

Cyanocobalamin sprays is cyanocobalamin Nasal Spray is indicated for:•Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement •Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia •Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normalLimitations of Use•Cyanocobalamin Nasal Spray should not be used for the vitamin B12 absorption test (Schilling test). This formulation utilizes a spray delivery system. Marketed by Padagis Israel Pharmaceuticals Ltd, this product is identified by NDC 45802-491 and is authorized under FDA application ANDA212458.

Identification & Billing

NDC Package Code
45802-491-84
Package Description
4 BOTTLE, UNIT-DOSE in 1 CARTON / 1 SPRAY in 1 BOTTLE, UNIT-DOSE
Product Code
45802-491
11-Digit Billing Format
45802049184
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cyanocobalamin
Non-Proprietary Name
Cyanocobalamin
Substance Name
Cyanocobalamin
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
CYANOCOBALAMIN 500 ug/1
Pharmacologic Class
Usage Information
Cyanocobalamin Nasal Spray is indicated for:•Vitamin B12 maintenance therapy in adult patients with pernicious anemia who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement •Treatment of adult patients with dietary, drug-induced, or malabsorption-related vitamin B12 deficiency not due to pernicious anemia •Prevention of vitamin B12 deficiency in adult patients with vitamin B12 requirements in excess of normalLimitations of Use•Cyanocobalamin Nasal Spray should not be used for the vitamin B12 absorption test (Schilling test). •In patients with correctible or temporary causes of vitamin B12 deficiency, the benefit of continued long-term use of Cyanocobalamin Nasal Spray following adequate correction of vitamin B12 deficiency and underlying disease has not been established. •The effectiveness of Cyanocobalamin Nasal Spray in patients with active symptoms of nasal congestion, allergic rhinitis or upper respiratory infection has not been determined. Treatment with Cyanocobalamin Nasal Spray should be deferred until symptoms have subsided.

Regulatory & Marketing

Labeler Name
Padagis Israel Pharmaceuticals Ltd
Product Type
Human Prescription Drug
FDA Application #
ANDA212458
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-28-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 45802-491-84 identifies a specific commercial package of 4 bottle, unit-dose in 1 carton / 1 spray in 1 bottle, unit-dose of Cyanocobalamin, a human prescription drug labeled by Padagis Israel Pharmaceuticals Ltd. This spray is formulated for nasal 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 Padagis Israel Pharmaceuticals Ltd on December 28, 2023. The current certification is valid through December 31, 2026.

How is this Padagis Israel Pharmaceuticals Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 45802049184. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 total billable units per package. 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)
45802-491-84
11-Digit CMS (5-4-2)
45802-0491-84

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