Theophylline Solution
NDC Package 27808-033-01

11-digit billing NDC: 27808003301 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Theophylline solution is theophylline oral solution is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. This formulation utilizes a solution delivery system. Marketed by Cranbury Pharmaceuticals, Llc, this product is identified by NDC 27808-033 and is authorized under FDA application ANDA091586.

Identification & Billing

NDC Package Code
27808-033-01
Package Description
473 mL in 1 BOTTLE
Product Code
27808-033
11-Digit Billing Format
27808003301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Theophylline
Non-Proprietary Name
Theophylline
Substance Name
Theophylline Anhydrous
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
THEOPHYLLINE ANHYDROUS 80 mg/15mL
Pharmacologic Class
Usage Information
Theophylline oral solution is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.

Regulatory & Marketing

Labeler Name
Cranbury Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA091586
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-02-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 27808-033-01 identifies a specific commercial package of 473 ml in 1 bottle of Theophylline, a human prescription drug labeled by Cranbury Pharmaceuticals, Llc. This solution is formulated for oral use and contains theophylline anhydrous 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 Cranbury Pharmaceuticals, Llc on August 02, 2012. The current certification is valid through December 31, 2027.

How is this Cranbury Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27808003301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
27808-033-01
11-Digit CMS (5-4-2)
27808-0033-01

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