Theophylline NDC 42291-922

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-922Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0922Add 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
42291-922-01	42291092201	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-922-01)Marketed from Apr 13, 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 anhydrous — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089763
Marketing start: Apr 13, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 42291-922_48bf9d36-1151-79d1-e063-6394a90aee09SPL ID 48bf9d36-1151-79d1-e063-6394a90aee09SPL set ID f93e20b1-97aa-088d-e053-6394a90a25d4RxCUI 317769UNII 0I55128JYKUPC 0342291922013
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

N442291092201 followed by a unit qualifier and the quantity

Package 42291-0922-01. 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 Jan 19, 2026.

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 089763

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

FDA NDC Directory listings under ANDA 089763
Product	Strength	Form · route	Labeler	Product NDC
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-741
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Chartwell RX, LLC	62135-457