What is NDC 69315-325?

69315-325 is the product NDC for Timolol Maleate, Timolol maleate 5 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 3 package NDCs, 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 Timolol Maleate?

47 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Timolol Maleate NDC 69315-325 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-325Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0325Add 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
69315-325-05	6931503250569315032505	5 mL in 1 BOTTLE, PLASTIC (69315-325-05)Marketed from Nov 7, 2024
69315-325-10	6931503251069315032510	10 mL in 1 BOTTLE, PLASTIC (69315-325-10)Marketed from Nov 7, 2024
69315-325-15	6931503251569315032515	15 mL in 1 BOTTLE, PLASTIC (69315-325-15)Marketed from Nov 7, 2024

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): Timolol Maleate
Generic name (nonproprietary): timolol maleate
Active ingredients: Timolol maleate — 5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218460
Marketing start: Nov 7, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 69315-325_b6fecc68-5e40-4191-a365-568ccedf0697SPL ID b6fecc68-5e40-4191-a365-568ccedf0697SPL set ID d6fa2971-dacf-42ab-99bc-c7ce6013221eRxCUI 1992303UNII P8Y54F701R
Pharmacologic class: beta-Adrenergic Blocker

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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469315032505 followed by a unit qualifier and the quantity

Package 69315-0325-05. 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 30, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-325

What is NDC 69315-325?: 69315-325 is the product NDC for Timolol Maleate, Timolol maleate 5 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Timolol Maleate.
What is the active ingredient?: Timolol maleate.
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 Timolol Maleate?: 47 other product NDCs are listed under this name. See all Timolol Maleate 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 Timolol Maleate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Timolol Maleate	Timolol maleate 2.5 mg/mL	Solution, Gel forming / dropsOphthalmic	Sagent Pharmaceuticals	25021-008	25021-0008-05
Timolol Maleate	Timolol maleate 5 mg/mL	Solution, Gel forming / dropsOphthalmic	Sagent Pharmaceuticals	25021-009	25021-0009-05
Timolol Maleate	Timolol maleate 5 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-223	16571-0223-01
Timolol Maleate	Timolol maleate 10 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-224	16571-0224-01
Timolol Maleate	Timolol maleate 20 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-225	16571-0225-01
timolol maleate	Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	NorthStar RxLLC	72603-540	72603-0540-01
Timolol Maleate	Timolol maleate 2.5 mg/mL	Solution, Gel forming / dropsOphthalmic	Somerset Therapeutics, LLC	70069-241	70069-0241-01
Timolol Maleate	Timolol maleate 5 mg/mL	Solution, Gel forming / dropsOphthalmic	Somerset Therapeutics, LLC	70069-251	70069-0251-01
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	A-S Medication Solutions	50090-7837	50090-7837-00
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	Caplin Steriles Limited	65145-152	65145-0152-01

All 48 Timolol Maleate NDCs

Other NDCs under ANDA 218460

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

FDA NDC Directory listings under ANDA 218460
Product	Strength	Form · route	Labeler	Product NDC
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	A-S Medication Solutions	50090-7837
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	Caplin Steriles Limited	65145-152
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	Caplin Steriles Limited	65145-153
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	Caplin Steriles Limited	65145-154