Theophylline NDC 69315-227

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-227Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0227Add 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
69315-227-01	69315022701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-227-01)Marketed from May 15, 2023

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): Theophylline
Generic name (nonproprietary): theophylline
Active ingredients: Theophylline — 450 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Leading Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214950
Marketing start: May 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 69315-227_a7dacdee-6f6b-4b85-b051-7779258a6971SPL ID a7dacdee-6f6b-4b85-b051-7779258a6971SPL set ID ac490ebf-24e1-47c4-a932-ad4dcafe7aadRxCUI 314241, 317769UNII C137DTR5RGUPC 0369315227015, 0369315226018
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

N469315022701 followed by a unit qualifier and the quantity

Package 69315-0227-01. 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 Oct 7, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE: Theophylline extended-release tablets are 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)

Other NDCs under ANDA 214950

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 214950
Product	Strength	Form · route	Labeler	Product NDC
Theophylline	Theophylline 300 mg/1	Tablet, Extended releaseOral	Leading Pharma, LLC	69315-226