Theophylline NDC 68462-356

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-356Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0356Add 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
68462-356-01	68462035601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-01)Marketed from Jul 13, 2010
68462-356-05	68462035605	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-356-05)Marketed from Jul 13, 2010

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 — 600 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090355
Marketing start: Jul 13, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 68462-356_7c8e32e3-ca36-4ad2-971b-446c12a81992SPL ID 7c8e32e3-ca36-4ad2-971b-446c12a81992SPL set ID 56fc2167-ceb6-4e3e-8ff7-5e400dfbd533RxCUI 313291, 348472UNII 0I55128JYKUPC 0368462380017, 0368462356012
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

N468462035601 followed by a unit qualifier and the quantity

Package 68462-0356-01. 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 29, 2026.

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)

Other NDCs under ANDA 090355

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

FDA NDC Directory listings under ANDA 090355
Product	Strength	Form · route	Labeler	Product NDC
Theophylline	Theophylline anhydrous 400 mg/1	Tablet, Extended releaseOral	Glenmark Pharmaceuticals Inc., USA	68462-380