Timolol Maleate
- Product NDC
- 65145-153
- 11-digit product format
- 651450153
- Labeler code
- 65145
- Product ID
- 65145-153_4847f180-45e6-40f0-ae8c-6cc500cb0add
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Caplin Steriles Limited
- Application
- ANDA218460
- Marketing category
- ANDA
- Marketing start
- 2024-09-16
- Substance
- TIMOLOL MALEATE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791 | Product name | 4 | 20251208 |
| 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 |
| d11e749b-f93e-0ce3-ceda-28fe03d8081d | Product name | 2 | 20190731 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65145-153-01 | Timolol Maleate | 1 in 1 CARTON | SOLUTION | 1 | 1 | |
| 65145-153-01 | Timolol Maleate | 10 mL in 1 BOTTLE | SOLUTION | 10 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65145-153-01 | ML - Milliliter | 65145-153 | 51181aef-08c2-4925-a7b3-28edd0bae8ab | 1 | 2025-05-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1992303 | timolol 0.5 % 12HR Ophthalmic Solution | PSN | 4847f180-45e6-40f0-ae8c-6cc500cb0add | 1 |
| 1992303 | timolol 0.5 % 12HR Ophthalmic Solution | PSN | 7a1ea848-5b55-4038-afb1-029645ee0925 | 1 |
| 1992303 | 12 HR timolol 5 MG/ML Ophthalmic Solution | SCD | 4847f180-45e6-40f0-ae8c-6cc500cb0add | 1 |
| 1992303 | 12 HR timolol 5 MG/ML Ophthalmic Solution | SCD | 7a1ea848-5b55-4038-afb1-029645ee0925 | 1 |
| 1992303 | timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution | SY | 4847f180-45e6-40f0-ae8c-6cc500cb0add | 1 |
| 1992303 | timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution | SY | 7a1ea848-5b55-4038-afb1-029645ee0925 | 1 |
| 1992303 | timolol 0.5 % 12 HR Ophthalmic Solution | SY | 4847f180-45e6-40f0-ae8c-6cc500cb0add | 1 |
| 1992303 | timolol 0.5 % 12 HR Ophthalmic Solution | SY | 7a1ea848-5b55-4038-afb1-029645ee0925 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 65145-153-01 | 65145015301 | 1 BOTTLE in 1 CARTON (65145-153-01) / 10 mL in 1 BOTTLE | 1 bottle | 2024-09-16 | No | No | Historical |