Prescription drug · ANDA
Timolol Maleate NDC 65145-152
Timolol maleate 5 mg/mL · Solution · Ophthalmic · Caplin Steriles Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65145-152-01 | 65145015201 | 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLEMarketed from Sep 16, 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 — 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 218460
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 65145-152_4847f180-45e6-40f0-ae8c-6cc500cb0addSPL ID 4847f180-45e6-40f0-ae8c-6cc500cb0addSPL set ID 4847f180-45e6-40f0-ae8c-6cc500cb0addRxCUI 1992303UNII P8Y54F701RUPC 0365145153012, 0365145152015, 0365145154019
- 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
N465145015201followed by a unit qualifier and the quantityPackage 65145-0152-01. 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)
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.
Other NDCs under ANDA 218460
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 5 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-7837 |
| Timolol Maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | Leading Pharma, LLC | 69315-325 |
| Timolol Maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | Caplin Steriles Limited | 65145-153 |
| Timolol Maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | Caplin Steriles Limited | 65145-154 |