Prescription drug · ANDA
timolol maleate NDC 81469-209
Timolol maleate 2.5 mg/mL · Solution/ drops · Ophthalmic · First Nation Group, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81469-209-05 | 8146902090581469020905 | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from May 10, 2024 | |
| 81469-209-10 | 8146902091081469020910 | 1 BOTTLE, DROPPER in 1 CARTON (81469-209-10) / 10 mL in 1 BOTTLE, DROPPERMarketed from May 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)
- timolol maleate
- Generic name (nonproprietary)
- timolol maleate
- Active ingredients
- Timolol maleate — 2.5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- First Nation Group, LLCNDC labeler code 81469
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078771
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 81469-209_b666fc6c-b409-45a6-a890-fa5b41585390SPL ID b666fc6c-b409-45a6-a890-fa5b41585390SPL set ID 140e1bfc-b75e-40d1-856c-242be4d9c8ccRxCUI 1923428, 1992303UNII P8Y54F701RUPC 0381469210057, 0381469210101, 0381469209105, 0381469209051
- 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
N481469020905followed by a unit qualifier and the quantityPackage 81469-0209-05. 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)
INDICATIONS AND USAGE Timolol maleate ophthalmic 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.
About NDC 81469-209
- What is NDC 81469-209?
- 81469-209 is the product NDC for timolol maleate, Timolol maleate 2.5 mg/mL solution/ drops, listed with the FDA by First Nation Group, LLC. It has 2 package NDCs, 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?
- First Nation Group, LLC, NDC labeler code 81469. 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.
Related NDCs: other timolol maleate products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 078771
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 |
|---|---|---|---|---|
| timolol maleate | Timolol maleate 2.5 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-654 |
| timolol maleate | Timolol maleate 2.5 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-655 |
| timolol maleate | Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-656 |
| timolol maleate | Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Lifestar Pharma LLC | 70756-657 |
| timolol maleate | Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | NorthStar RxLLC | 72603-540 |
| timolol maleate | Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | First Nation Group, LLC | 81469-210 |