Timolol Maleate
- Product NDC
- 25021-008
- 11-digit product format
- 250210008
- Labeler code
- 25021
- Product ID
- 25021-008_ff0af07d-608a-44c6-936a-f22e726d3f41
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION, GEL FORMING / DROPS
- Route
- OPHTHALMIC
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA214645
- Marketing category
- ANDA
- Marketing start
- 2026-01-15
- Substance
- TIMOLOL MALEATE
- Active strength
- 2.5 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Timolol Maleate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| TIMOLOL MALEATE | 2.5 mg/mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | P8Y54F701R |
| Rxcui | 313407, 313408 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791 | Product name | 4 | 20251208 |
| 77dc03a4-fbfc-e6a3-fe95-285bbae40d75 | Product name | 2 | 20250814 |
| 73103a56-9f57-4f32-a306-a42bfa2fea36 | Product name | 1 | 20250505 |
| 425025fc-f910-4afe-815b-58d4486ed4f7 | Product name | 4 | 20250331 |
| 26c5ddae-5c69-622d-e599-5fd583634968 | Product name | 4 | 20250313 |
| ee780602-134c-4c60-a2f0-e973ba549cd4 | Product name | 2 | 20250304 |
| 03f77cb2-b4ad-3c11-8781-787b5ece4291 | Product name | 3 | 20240507 |
| 273981e4-09e7-45cc-967c-554f628ededf | Product name | 3 | 20230627 |
| 97dad5a2-c524-a7b5-dede-82edefe9ce62 | Product name | 7 | 20220929 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| d11e749b-f93e-0ce3-ceda-28fe03d8081d | Product name | 2 | 20190731 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 25021-008-05 | Timolol Maleate | 5 mL in 1 BOTTLE | SOLUTION, GEL FORMING / DROPS | 5 | 1 | |
| 25021-008-05 | Timolol Maleate | 1 in 1 CARTON | SOLUTION, GEL FORMING / DROPS | 1 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 25021-008-05 | ML - Milliliter | 25021-008 | b97a0f98-3a00-4214-a2a1-679e5caa380c | 1 | 2026-03-17 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313407 | timolol maleate 0.25 % Ophthalmic Gel Forming Solution | PSN | 272bb565-f099-4896-b2f6-48ab9180e941 | 1 |
| 313408 | timolol maleate 0.5 % Ophthalmic Gel Forming Solution | PSN | 272bb565-f099-4896-b2f6-48ab9180e941 | 1 |
| 313407 | timolol 0.0025 MG/MG Ophthalmic Gel | SCD | 272bb565-f099-4896-b2f6-48ab9180e941 | 1 |
| 313408 | timolol 0.005 MG/MG Ophthalmic Gel | SCD | 272bb565-f099-4896-b2f6-48ab9180e941 | 1 |
| 313407 | timolol 0.25 % Ophthalmic Gel | SY | 272bb565-f099-4896-b2f6-48ab9180e941 | 1 |
| 313407 | timolol 0.25 % Ophthalmic Gel Forming Solution | SY | 272bb565-f099-4896-b2f6-48ab9180e941 | 1 |
| 313408 | timolol 0.5 % (as timolol maleate 6.8 MG/ML) Ophthalmic Gel | SY | 272bb565-f099-4896-b2f6-48ab9180e941 | 1 |
| 313408 | timolol 0.5 % Gel Forming Ophthalmic Solution | SY | 272bb565-f099-4896-b2f6-48ab9180e941 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 25021-008-05 | 25021000805 | 1 BOTTLE in 1 CARTON (25021-008-05) / 5 mL in 1 BOTTLE | 1 bottle | 2026-01-15 | No | No | Historical |