Hydroxocobalamin Injection, Solution
NDC Package 0591-2888-30

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

Hydroxocobalamin injection is hydroxocobalamin is a man-made injectable form of vitamin B12 used to treat low levels (deficiency) of this vitamin. This formulation utilizes a injection, solution delivery system. Marketed by Actavis Pharma, Inc., this product is identified by NDC 0591-2888 and is authorized under FDA application ANDA085998.

Identification & Billing

NDC Package Code
0591-2888-30
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 30 mL in 1 VIAL, MULTI-DOSE
Product Code
0591-2888
11-Digit Billing Format
00591288830
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 317106 - hydroxocobalamin 1000 MCG/ML Injectable Solution
  • RxCUI: 317106 - hydroxocobalamin 1 MG/ML Injectable Solution
  • RxCUI: 317106 - hydroxocobalamin (as hydroxocobalamin acetate) 1000 MCG/ML Injectable Solution

Clinical Specifications

Proprietary Name
Hydroxocobalamin
Non-Proprietary Name
Hydroxocobalamin
Substance Name
Hydroxocobalamin Acetate
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)
HYDROXOCOBALAMIN ACETATE 1000 ug/mL
Pharmacologic Class
Antidote - [EPC] (Established Pharmacologic Class)
Usage Information
Hydroxocobalamin is a man-made injectable form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA085998
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-12-2010
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.

J3425
Source: ASP
Hydroxocobalamin im 10mcg
HCPCS Dosage 10 MCG
Units / Pkg 3000

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 0591-2888-30 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 30 ml in 1 vial, multi-dose of Hydroxocobalamin, a human prescription drug labeled by Actavis Pharma, Inc.. This injection, solution is formulated for intramuscular use and contains hydroxocobalamin acetate 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 Actavis Pharma, Inc. on November 12, 2010. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Hydroxocobalamin is a man-made injectable form of vitamin B12 used to treat low levels (deficiency) of this vitamin. Vitamin B12 helps your body use fat and carbohydrates for energy and make new protein. It is also important for normal blood, cells, and nerves. Most people get enough vitamin B12 in their diet, but a deficiency may occur in certain health conditions (e.g., poor nutrition, stomach/intestinal problems, infection, cancer). Serious vitamin B12 deficiency may result in anemia, stomach problems, and nerve damage.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00591288830. 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 (4-4-2)
0591-2888-30
11-Digit CMS (5-4-2)
00591-2888-30

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