What is NDC 59651-313?

59651-313 is the product NDC for Timolol Maleate, Timolol maleate 5 mg/mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. 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 59651-313 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-313Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0313Add 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
59651-313-05	5965103130559651031305	1 BOTTLE, DISPENSING in 1 CARTON (59651-313-05) / 5 mL in 1 BOTTLE, DISPENSINGMarketed from Mar 23, 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): Timolol Maleate
Generic name (nonproprietary): timolol maleate
Active ingredients: Timolol maleate — 5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213540
Marketing start: Mar 23, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 59651-313_a3be9b06-b9bc-42e2-b3fd-4f34d6978ff2SPL ID a3be9b06-b9bc-42e2-b3fd-4f34d6978ff2SPL set ID e6c74f66-ee84-4bcc-b1da-b8e6ff240dd2RxCUI 313408UNII 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

N459651031305 followed by a unit qualifier and the quantity

Package 59651-0313-05. 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 May 16, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Timolol maleate ophthalmic gel forming 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 59651-313

What is NDC 59651-313?: 59651-313 is the product NDC for Timolol Maleate, Timolol maleate 5 mg/mL solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, 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?: Aurobindo Pharma Limited, NDC labeler code 59651. 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