Theo-24 (theophylline anhydrous) NDC 52244-400

NDC codes

FDA NDC Directory

Product NDC (as listed)52244-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width52244-0400Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
52244-400-10	52244040010	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-400-10)Marketed from Aug 25, 2014

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Theo-24
Generic name (nonproprietary): theophylline anhydrous
Active ingredients: Theophylline anhydrous — 400 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: ENDO USA, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 081034
Marketing start: Aug 25, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 52244-400_95d19693-50ba-43fc-81fe-6cddc537703aSPL ID 95d19693-50ba-43fc-81fe-6cddc537703aSPL set ID 7a108fa0-c230-475f-be93-6f864b98a410RxCUI 198264, 313272, 313310, 701712, 844590, 844591, 844813, 844829UNII 0I55128JYK
Pharmacologic class: Methylxanthine

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N452244040010 followed by a unit qualifier and the quantity

Package 52244-0400-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jul 8, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Theophylline 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)