What is NDC 61314-227?

61314-227 is the product NDC for Timolol Maleate, Timolol maleate 5 mg/mL solution, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 61314. 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 61314-227 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-227Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0227Add 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
61314-227-05	6131402270561314022705	1 BOTTLE, PLASTIC in 1 CARTON (61314-227-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from Jan 15, 1996
61314-227-10	6131402271061314022710	1 BOTTLE, PLASTIC in 1 CARTON (61314-227-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from Jan 15, 1996
61314-227-15	6131402271561314022715	1 BOTTLE, PLASTIC in 1 CARTON (61314-227-15) / 15 mL in 1 BOTTLE, PLASTICMarketed from Jan 15, 1996

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: Sandoz IncNDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074262
Marketing start: Jan 15, 1996
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 61314-227_f17a3387-424e-4d1a-8bf4-0d870305e507SPL ID f17a3387-424e-4d1a-8bf4-0d870305e507SPL set ID f949fa34-6a9a-40d5-91ab-ff1cbb79b9eaRxCUI 1923428, 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

N461314022705 followed by a unit qualifier and the quantity

Package 61314-0227-05. 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 Feb 20, 2026.

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 61314-227

What is NDC 61314-227?: 61314-227 is the product NDC for Timolol Maleate, Timolol maleate 5 mg/mL solution, listed with the FDA by Sandoz Inc. 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?: Sandoz Inc, NDC labeler code 61314. 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 5 mg/mL	SolutionOphthalmic	Leading Pharma, LLC	69315-325	69315-0325-0569315-0325-1069315-0325-15
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

All 48 Timolol Maleate NDCs

Other NDCs under ANDA 074262

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

FDA NDC Directory listings under ANDA 074262
Product	Strength	Form · route	Labeler	Product NDC
Timolol Maleate	Timolol maleate 5 mg/mL	SolutionOphthalmic	A-S Medication Solutions	50090-3441