Cortef Tablet
NDC Package 0009-0044-01

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

Package Information

Cortef (hydrocortisone) tablets is hydrocortisone is a natural substance (corticosteroid hormone) made by the adrenal gland. This formulation utilizes a tablet delivery system. Marketed by Pharmacia & Upjohn Company Llc, this product is identified by NDC 0009-0044 and is authorized under FDA application NDA008697.

Identification & Billing

NDC Package Code
0009-0044-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
0009-0044
11-Digit Billing Format
00009004401
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cortef
Non-Proprietary Name
Hydrocortisone
Substance Name
Hydrocortisone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
HYDROCORTISONE 20 mg/1
Pharmacologic Class
Usage Information
Hydrocortisone is a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood/hormone/immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions. Hydrocortisone is also used to treat low hydrocortisone levels caused by diseases of the adrenal gland (such as Addison's disease, adrenocortical insufficiency). Corticosteroids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal.

Regulatory & Marketing

Labeler Name
Pharmacia & Upjohn Company Llc
Product Type
Human Prescription Drug
FDA Application #
NDA008697
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
12-15-1952
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0009-0044-01 identifies a specific commercial package of 100 tablet in 1 bottle of Cortef, a human prescription drug labeled by Pharmacia & Upjohn Company Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains hydrocortisone 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 Pharmacia & Upjohn Company Llc on December 15, 1952. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Hydrocortisone is a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood/hormone/immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions. Hydrocortisone is also used to treat low hydrocortisone levels caused by diseases of the adrenal gland (such as Addison's disease, adrenocortical insufficiency). Corticosteroids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal.

How is this Pharmacia & Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009004401. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
0009-0044-01
11-Digit CMS (5-4-2)
00009-0044-01

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