Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% NDC 46708-545

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-545Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0545Add 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
46708-545-05	46708054505	1 BOTTLE in 1 CARTON (46708-545-05) / 5 mL in 1 BOTTLEMarketed from Nov 22, 2020

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 Ophthalmic Gel Forming Solution, 0.25%
Generic name (nonproprietary): timolol maleate ophthalmic gel forming solution, 0.25%
Active ingredients: Timolol maleate — 2.5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212942
Marketing start: Nov 22, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 46708-545_9a5aab8f-59b9-4d73-82c4-dc5b8fa8119eSPL ID 9a5aab8f-59b9-4d73-82c4-dc5b8fa8119eSPL set ID 9a5aab8f-59b9-4d73-82c4-dc5b8fa8119eRxCUI 313407, 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

N446708054505 followed by a unit qualifier and the quantity

Package 46708-0545-05. 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 Apr 25, 2025.

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)

Other NDCs under ANDA 212942

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

FDA NDC Directory listings under ANDA 212942
Product	Strength	Form · route	Labeler	Product NDC
Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-546
Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%	Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Limited	46708-546
Timolol Maleate Ophthalmic Gel Forming Solution, 0.25%	Timolol maleate 2.5 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-545