Prescription drug · ANDA
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution (Brimonidine tartrate and timolol maleate) NDC 69315-330
Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL · Solution · Ophthalmic · Leading Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-330-05 | 6931503300569315033005 | 1 BOTTLE, DROPPER in 1 CARTON (69315-330-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 29, 2025 | |
| 69315-330-10 | 6931503301069315033010 | 1 BOTTLE, DROPPER in 1 CARTON (69315-330-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from May 29, 2025 | |
| 69315-330-15 | 6931503301569315033015 | 1 BOTTLE, DROPPER in 1 CARTON (69315-330-15) / 15 mL in 1 BOTTLE, DROPPERMarketed from May 29, 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
- Leading Pharma, LLCNDC labeler code 69315
- 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 69315-330_16b451fa-d16e-4138-a5b9-e4424e56920bSPL ID 16b451fa-d16e-4138-a5b9-e4424e56920bSPL set ID 533f9979-0cd7-485c-8c50-abbf717c5031RxCUI 861635UNII 4S9CL2DY2H, P8Y54F701RUPC 0369315330050, 0369315330104, 0369315330159
- 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
N469315033005followed by a unit qualifier and the quantityPackage 69315-0330-05. 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 .
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.
About NDC 69315-330
- What is NDC 69315-330?
- 69315-330 is the product NDC for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution (Brimonidine Tartrate and Timolol Maleate).
- What is the active ingredient?
- Brimonidine tartrate, Timolol maleate.
- Who is the labeler?
- Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution?
- 4 other product NDCs are listed under this name. See all Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solutionbrimonidine tartrate and timolol maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Caplin Steriles Limited | 65145-162 | 65145-0162-01 |
| 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 | 65145-0163-01 |
| 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 | 65145-0164-01 |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solutionbrimonidine tartrate and timolol maleate | Brimonidine tartrate 2 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Apotex Corp. | 60505-0589 | 60505-0589-0160505-0589-0260505-0589-03 |
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 | Caplin Steriles Limited | 65145-162 |
| 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 |