Calcitonin Salmon Injection, Solution
NDC Package 43598-051-11

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

Calcitonin Salmon injection is calcitonin-salmon injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. This formulation utilizes a injection, solution delivery system. Marketed by Dr. Reddy's Laboratories, Inc., this product is identified by NDC 43598-051 and is authorized under FDA application ANDA215715.

Identification & Billing

NDC Package Code
43598-051-11
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 2 mL in 1 VIAL, MULTI-DOSE
Product Code
43598-051
11-Digit Billing Format
43598005111
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Calcitonin Salmon
Non-Proprietary Name
Calcitonin Salmon
Substance Name
Calcitonin Salmon
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.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
CALCITONIN SALMON 200 [USP'U]/mL
Pharmacologic Class
Usage Information
Calcitonin-salmon injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin-salmon is beneficial in asymptomatic patients. Calcitonin-salmon injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).

Regulatory & Marketing

Labeler Name
Dr. Reddy's Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA215715
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-17-2024
Listing Expiration
12-31-2027
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.

J0630
Source: PDAC
INJECTION, CALCITONIN SALMON, UP TO 400 UNITS
HCPCS Dosage 400 IU
Units / Pkg

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 43598-051-11 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 2 ml in 1 vial, multi-dose of Calcitonin Salmon, a human prescription drug labeled by Dr. Reddy's Laboratories, Inc.. This injection, solution is formulated for intramuscular; subcutaneous use and contains calcitonin salmon 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 Dr. Reddy's Laboratories, Inc. on June 17, 2024. The current certification is valid through December 31, 2027.

How is this Dr. Reddy's Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43598005111. 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)
43598-051-11
11-Digit CMS (5-4-2)
43598-0051-11

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