Ergocalciferol Capsule, Liquid Filled
NDC Package 43353-238-08

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

Package Information

Ergocalciferol capsules is vitamin D (ergocalciferol-D2, cholecalciferol-D3, alfacalcidol) is a fat-soluble vitamin that helps your body absorb calcium and phosphorus. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Aphena Pharma Solutions - Tennessee, Llc, this product is identified by NDC 43353-238 and is authorized under FDA application ANDA080704.

Identification & Billing

NDC Package Code
43353-238-08
Package Description
8 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
43353-238
11-Digit Billing Format
43353023808
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
8 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ergocalciferol
Non-Proprietary Name
Ergocalciferol
Substance Name
Ergocalciferol
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ERGOCALCIFEROL 1.25 mg/1
Pharmacologic Class
Usage Information
Vitamin D (ergocalciferol-D2, cholecalciferol-D3, alfacalcidol) is a fat-soluble vitamin that helps your body absorb calcium and phosphorus. Having the right amount of vitamin D, calcium, and phosphorus is important for building and keeping strong bones. Vitamin D is used to treat and prevent bone disorders (such as rickets, osteomalacia). Vitamin D is made by the body when skin is exposed to sunlight. Sunscreen, protective clothing, limited exposure to sunlight, dark skin, and age may prevent getting enough vitamin D from the sun. Vitamin D with calcium is used to treat or prevent bone loss (osteoporosis). Vitamin D is also used with other medications to treat low levels of calcium or phosphate caused by certain disorders (such as hypoparathyroidism, pseudohypoparathyroidism, familial hypophosphatemia). It may be used in kidney disease to keep calcium levels normal and allow normal bone growth. Vitamin D drops (or other supplements) are given to breast-fed infants because breast milk usually has low levels of vitamin D.

Regulatory & Marketing

Labeler Name
Aphena Pharma Solutions - Tennessee, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA080704
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-23-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43353-238). Click a package code to view its specific billing and regulatory data.

43353-238-03
3 CAPSULE, LIQUID FILLED in 1 BOTTLE
43353-238-04
4 CAPSULE, LIQUID FILLED in 1 BOTTLE
43353-238-12
12 CAPSULE, LIQUID FILLED in 1 BOTTLE
43353-238-13
13 CAPSULE, LIQUID FILLED in 1 BOTTLE

* 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 43353-238-08 identifies a specific commercial package of 8 capsule, liquid filled in 1 bottle of Ergocalciferol, a human prescription drug labeled by Aphena Pharma Solutions - Tennessee, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 8 billable units per package. This capsule, liquid filled is formulated for oral use and contains ergocalciferol 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 Aphena Pharma Solutions - Tennessee, Llc on July 23, 2015. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Vitamin D (ergocalciferol-D2, cholecalciferol-D3, alfacalcidol) is a fat-soluble vitamin that helps your body absorb calcium and phosphorus. Having the right amount of vitamin D, calcium, and phosphorus is important for building and keeping strong bones. Vitamin D is used to treat and prevent bone disorders (such as rickets, osteomalacia). Vitamin D is made by the body when skin is exposed to sunlight. Sunscreen, protective clothing, limited exposure to sunlight, dark skin, and age may prevent getting enough vitamin D from the sun. Vitamin D with calcium is used to treat or prevent bone loss (osteoporosis). Vitamin D is also used with other medications to treat low levels of calcium or phosphate caused by certain disorders (such as hypoparathyroidism, pseudohypoparathyroidism, familial hypophosphatemia). It may be used in kidney disease to keep calcium levels normal and allow normal bone growth. Vitamin D drops (or other supplements) are given to breast-fed infants because breast milk usually has low levels of vitamin D.

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: 43353023808. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 8 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)
43353-238-08
11-Digit CMS (5-4-2)
43353-0238-08

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