Prescription drug · NDA
Timolol GFS (Timolol maleate) NDC 61314-225
Timolol maleate 5 mg/mL · Solution, Gel forming / drops · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-225-05 | 6131402250561314022505 | 5 mL in 1 BOTTLE (61314-225-05)Marketed from Dec 24, 1998 | |
| 61314-225-25 | 6131402252561314022525 | 2.5 mL in 1 BOTTLE (61314-225-25)Marketed from Dec 24, 1998 |
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 GFS
- Generic name (nonproprietary)
- timolol maleate
- Active ingredients
- Timolol maleate — 5 mg/mL
- Dosage form
- Solution, Gel forming / drops
- Route
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020963
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 61314-225_ba538348-67cf-4031-84e5-cb84647af104SPL ID ba538348-67cf-4031-84e5-cb84647af104SPL set ID 72b0d0ec-832a-4c25-b845-2537ab506354RxCUI 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
N461314022505followed by a unit qualifier and the quantityPackage 61314-0225-05. 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)
Timolol GFS 0.25% and 0.5% are indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Timolol GFS is a beta adrenergic blocker indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 61314-225
- What is NDC 61314-225?
- 61314-225 is the product NDC for Timolol GFS (timolol maleate), Timolol maleate 5 mg/mL solution, gel forming / drops, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Timolol GFS (Timolol maleate).
- What is the active ingredient?
- Timolol maleate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 61314. 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 GFS?
- 1 other product NDC are listed under this name. See all Timolol GFS NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Timolol GFS 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 GFStimolol maleate | Timolol maleate 2.5 mg/mL | Solution, Gel forming / dropsOphthalmic | Sandoz Inc | 61314-224 | 61314-0224-0561314-0224-25 |
Other NDCs under NDA 020963
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 GFStimolol maleate | Timolol maleate 2.5 mg/mL | Solution, Gel forming / dropsOphthalmic | Sandoz Inc | 61314-224 |