Hydroxocobalamin Injection, Solution
NDC Package 0591-2888-30

11-digit billing NDC: 00591288830 · Billing unit: ML · 30 ML per package
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Hydroxocobalamin injection is pernicious anemia, both uncomplicated and accompanied by nervous system involvement.Dietary deficiency of Vitamin B12, occurring in strict vegetarians and in their breast-fed infants. 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.
Units Per Package
30 ML
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
Pernicious anemia, both uncomplicated and accompanied by nervous system involvement.Dietary deficiency of Vitamin B12, occurring in strict vegetarians and in their breast-fed infants. (Isolated vitamin B12 deficiency is very rare).Malabsorption of vitamin B12, resulting from structural or functional damage to the stomach, where intrinsic factor is secreted or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency.Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency.Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.Competition for Vitamin B12 by intestinal parasites or bacteria.The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind-loop syndrome may produce deficiency of Vitamin B12 or folate.Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.For the Schilling Test.

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.

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.. There are 30 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 (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.