Calcitriol
NDC Package 43353-034-81
Package Information
Calcitriol is a man-made active form of vitamin D. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-034 and is authorized under FDA application ANDA076917.
Identification & Billing
- RxCUI: 308867 - calcitriol 0.25 MCG Oral Capsule
- RxCUI: 308867 - calcitriol 0.00025 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 43353 - Aphena Pharma Solutions - Tennessee, Llc
- 43353-034 - Calcitriol
- 43353-034-81 - 800 CAPSULE in 1 BOTTLE, PLASTIC
- 43353-034 - Calcitriol
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.
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Other Available Packages
The following commercial packages are registered under the same Product NDC (43353-034). Click a package code to view its specific billing and regulatory data.
* 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 43353-034-81 identifies a specific commercial package of 800 capsule in 1 bottle, plastic of Calcitriol, labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 800 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Aphena Pharma Solutions - Tennessee, Llc on March 27, 2006. The current certification is valid through December 31, 2022.
What are the primary indications for this medication?
Calcitriol is a man-made active form of vitamin D. Most people get enough vitamin D from exposure to the sun and from fortified food products (e.g., dairy products, vitamins). Vitamin D helps control parathyroid hormone and the levels of certain minerals (e.g., calcium, phosphorus) that are needed for building and keeping strong bones. Before regular vitamin D can be used by the body, it needs to be changed to the active form by the liver and kidneys. Calcitriol is used in patients with kidney disease who can't make enough of the active form of Vitamin D. This medication is also used to prevent and treat certain types of calcium/phosphorus/parathyroid problems that can happen with long-term kidney dialysis or hypoparathyroidism. Calcitriol is usually used along with specific diet recommendations and sometimes other medications.
How is this Aphena Pharma Solutions - Tennessee, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43353003481. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 800 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.