Prescription drug · ANDA
Timolol Maleate NDC 25021-008
Timolol maleate 2.5 mg/mL · Solution, Gel forming / drops · Ophthalmic · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-008-05 | 2502100080525021000805 | 1 BOTTLE in 1 CARTON (25021-008-05) / 5 mL in 1 BOTTLEMarketed from Jan 15, 2026 |
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, Gel forming / drops
- Route
- Ophthalmic
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- 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 25021-008_ff0af07d-608a-44c6-936a-f22e726d3f41SPL ID ff0af07d-608a-44c6-936a-f22e726d3f41SPL set ID 272bb565-f099-4896-b2f6-48ab9180e941RxCUI 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
N425021000805followed by a unit qualifier and the quantityPackage 25021-0008-05. 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 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.
About NDC 25021-008
- What is NDC 25021-008?
- 25021-008 is the product NDC for Timolol Maleate, Timolol maleate 2.5 mg/mL solution, gel forming / drops, listed with the FDA by Sagent Pharmaceuticals. It has 1 package NDC, 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?
- Sagent Pharmaceuticals, NDC labeler code 25021. 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 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 |
| Timolol Maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | Caplin Steriles Limited | 65145-152 | 65145-0152-01 |
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 | 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 | Gland Pharma Limited | 68083-457 |
| timolol maleate ophthalmic gel forming solutiontimolol maleate ophthalmic gel forming | Timolol maleate 5 mg/mL | Solution, Gel forming / dropsOphthalmic | Gland Pharma Limited | 68083-458 |
| 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 |