Theophylline NDC 68462-721

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-721Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0721Add 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
68462-721-01	68462072101	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-01)Marketed from Jun 3, 2021
68462-721-05	68462072105	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-05)Marketed from Jun 3, 2021
68462-721-10	68462072110	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-10)Marketed from Jun 3, 2021
68462-721-30	68462072130	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68462-721-30)Marketed from Jun 3, 2021

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: Glenmark Pharmaceuticals Inc., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212184
Marketing start: Jun 3, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Xanthines (Chemical structure)
Identifiers: Product ID 68462-721_588a56f6-ac5a-415e-99ac-fdb836e0202fSPL ID 588a56f6-ac5a-415e-99ac-fdb836e0202fSPL set ID 48330a8e-be08-4d38-b8b1-d30fbd5a35deRxCUI 314241, 317769UNII 0I55128JYKUPC 0368462721018, 0368462722015
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

N468462072101 followed by a unit qualifier and the quantity

Package 68462-0721-01. 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 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 212184

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

FDA NDC Directory listings under ANDA 212184
Product	Strength	Form · route	Labeler	Product NDC
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Glenmark Pharmaceuticals Inc., USA	68462-722