What is NDC 69315-226?

69315-226 is the product NDC for Theophylline, Theophylline 300 mg/1 tablet, extended release, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Theophylline?

40 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Theophylline NDC 69315-226 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-226Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0226Add 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
69315-226-01	69315022601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-226-01)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 — 300 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Leading Pharma, LLCNDC labeler code 69315
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 69315-226_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

N469315022601 followed by a unit qualifier and the quantity

Package 69315-0226-01. 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)

About NDC 69315-226

What is NDC 69315-226?: 69315-226 is the product NDC for Theophylline, Theophylline 300 mg/1 tablet, extended release, listed with the FDA by Leading Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Theophylline.
What is the active ingredient?: Theophylline.
Who is the labeler?: Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Theophylline?: 40 other product NDCs are listed under this name. See all Theophylline NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Theophylline NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Ajanta Pharma USA Inc.	27241-272	27241-0272-01
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Ajanta Pharma USA Inc.	27241-273	27241-0273-01
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-441	72789-0441-01
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-442	72789-0442-01
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Strides Pharma Science Limited	64380-243	64380-0243-01
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Strides Pharma Science Limited	64380-244	64380-0244-01
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Harman Finochem Limited	82638-105	82638-0105-02
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Harman Finochem Limited	82638-106	82638-0106-02
Theophylline	Theophylline anhydrous 300 mg/1	Tablet, Extended releaseOral	Viona Pharmaceuticals Inc	72578-173	72578-0173-01
Theophylline	Theophylline anhydrous 450 mg/1	Tablet, Extended releaseOral	Viona Pharmaceuticals Inc	72578-174	72578-0174-01

All 41 Theophylline NDCs

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 450 mg/1	Tablet, Extended releaseOral	Leading Pharma, LLC	69315-227