Prescription drug · ANDA
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution NDC 65145-162
brimonidine tartrate and timolol maleate · Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL · Solution · Ophthalmic · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-162-01 | 65145016201 | 1 BOTTLE, DROPPER in 1 CARTON (65145-162-01) / 5 mL in 1 BOTTLE, DROPPERMarketed from Mar 10, 2025 |
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/Timolol Maleate Ophthalmic Solution
- Generic name (nonproprietary)
- brimonidine tartrate and timolol maleate
- Active ingredients
- Brimonidine tartrate — 2 mg/mLTimolol maleate — 5 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Caplin Steriles Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219093
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 65145-162_eac3cec2-b373-4936-89f0-c6d300e09f6eSPL ID eac3cec2-b373-4936-89f0-c6d300e09f6eSPL set ID eac3cec2-b373-4936-89f0-c6d300e09f6eRxCUI 861635UNII P8Y54F701R, 4S9CL2DY2HUPC 0365145162014, 0365145163011, 0365145164018
- 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
N465145016201followed by a unit qualifier and the quantityPackage 65145-0162-01. 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 .
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 So…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 219093
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solutionbrimonidine tartrate and timolol maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Leading Pharma, LLC | 69315-330 |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solutionbrimonidine tartrate and timolol maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Caplin Steriles Limited | 65145-163 |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solutionbrimonidine tartrate and timolol maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Caplin Steriles Limited | 65145-164 |