Prescription drug · ANDA
timolol maleate ophthalmic gel forming solution NDC 68083-458
timolol maleate ophthalmic gel forming · Timolol maleate 5 mg/mL · Solution, Gel forming / drops · Ophthalmic · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-458-01 | 68083045801 | 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLEMarketed from Feb 14, 2023 |
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 ophthalmic gel forming solution
- Generic name (nonproprietary)
- timolol maleate ophthalmic gel forming
- Active ingredients
- Timolol maleate — 5 mg/mL
- Dosage form
- Solution, Gel forming / drops
- Route
- Ophthalmic
- Labeler
- Gland Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214645
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 68083-458_0c73f98d-4f49-415a-abc5-2d253061e669SPL ID 0c73f98d-4f49-415a-abc5-2d253061e669SPL set ID 79730e4f-d533-42c7-b7b6-cdbc47242baaRxCUI 313407, 313408UNII P8Y54F701RUPC 0368083457013
- 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
N468083045801followed by a unit qualifier and the quantityPackage 68083-0458-01. 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 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 ANDA 214645
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 ophthalmic gel forming solution | Timolol maleate 2.5 mg/mL | Solution, Gel forming / dropsOphthalmic | Gland Pharma Limited | 68083-457 |
| Timolol Maleate | Timolol maleate 2.5 mg/mL | Solution, Gel forming / dropsOphthalmic | Sagent Pharmaceuticals | 25021-008 |
| Timolol Maleate | Timolol maleate 5 mg/mL | Solution, Gel forming / dropsOphthalmic | Sagent Pharmaceuticals | 25021-009 |
| Timolol Maleate Ophthalmic Gel Forming Solution | Timolol maleate 2.5 mg/mL | Solution, Gel forming / dropsOphthalmic | FOSUN PHARMA USA INC | 72266-199 |
| Timolol Maleate Ophthalmic Gel Forming Solution | Timolol maleate 5 mg/mL | Solution, Gel forming / dropsOphthalmic | FOSUN PHARMA USA INC | 72266-200 |