Prescription drug · NDA AUTHORIZED GENERIC
Timolol Maleate NDC 82260-819
Timolol maleate 5 mg/mL · Solution · Ophthalmic · Bausch & Lomb Americas Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82260-819-05 | 82260081905 | 1 BOTTLE, DISPENSING in 1 CARTON (82260-819-05) / 5 mL in 1 BOTTLE, DISPENSINGMarketed from Feb 14, 2018 |
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
- Bausch & Lomb Americas Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020330
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 82260-819_31420e86-ee3b-e6b1-e063-6394a90aefc7SPL ID 31420e86-ee3b-e6b1-e063-6394a90aefc7SPL set ID 581f80f7-4419-49e2-867d-40443c75409fRxCUI 313407, 313408UNII P8Y54F701R
- 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
N482260081905followed by a unit qualifier and the quantityPackage 82260-0819-05. 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 Sterile Ophthalmic Gel Forming 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 NDA 020330
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 | SolutionOphthalmic | Bausch & Lomb Americas Inc. | 82260-818 |
| Timoptic-XEtimolol maleate | Timolol maleate 2.5 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-814 |
| Timoptic-XEtimolol maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | Bausch & Lomb Incorporated | 24208-816 |