Brimonidine Tartrate and Timolol Maleate NDC 70069-652

NDC codes

FDA NDC Directory

Product NDC (as listed)70069-652Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70069-0652Add 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
70069-652-01	70069065201	1 BOTTLE in 1 CARTON (70069-652-01) / 10 mL in 1 BOTTLEMarketed from Oct 10, 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): Brimonidine Tartrate and Timolol Maleate
Generic name (nonproprietary): brimonidine tartrate and timolol maleate
Active ingredients: Brimonidine tartrate — 2 mg/mLTimolol maleate — 5 mg/mL
Dosage form: Solution/ drops
Route: Ophthalmic
Labeler: Somerset Therapeutics, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216114
Marketing start: Oct 10, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 70069-652_c456714b-707d-4449-b114-de5329846b94SPL ID c456714b-707d-4449-b114-de5329846b94SPL set ID e4fdbd17-73b7-49ed-9de3-591f36e0645dRxCUI 861635UNII P8Y54F701R, 4S9CL2DY2HUPC 0370069652015, 0370069651018, 0370069653012
Pharmacologic class: alpha-Adrenergic Agonist; 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

N470069065201 followed by a unit qualifier and the quantity

Package 70069-0652-01. 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 14, 2024.

Indications (excerpt from the label)

Brimonidine tartrate/timolol maleate ophthalmic solution 0.2%/0.5% is an alpha- adrenergic receptor agonist with a beta-adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of brimonidine tartrate/timolol maleate ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. Brimonidine tartrate/timolol maleate ophthalmic s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216114

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

FDA NDC Directory listings under ANDA 216114
Product	Strength	Form · route	Labeler	Product NDC
Brimonidine Tartrate and Timolol Maleate	Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-651
Brimonidine Tartrate and Timolol Maleate	Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-653