Timolol Maleate
- Product NDC
- 50090-3441
- 11-digit product format
- 500903441
- Labeler code
- 50090
- Product ID
- 50090-3441_78aae6ba-6716-47f9-994d-901bcdf1696a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- A-S Medication Solutions
- Application
- ANDA074262
- Marketing category
- ANDA
- Marketing start
- 1996-01-15
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-3441-0 | 2024-12-19 | C162847 | 48780-1 | f386c649-c716-0266-e053-dadaa90a7c1a | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 50090-3441-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-c716-0266-e053-dadaa90a7c1a | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-3441-0 | Timolol Maleate | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-3441-0 | ML - Milliliter | 50090-3441 | 1ea2b806-0dec-4e7e-aa0d-4bf6c66b8c9e | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-3441 | TIMOLOL MALEATE SOLUTION [A-S MEDICATION SOLUTIONS] | 5 | Current NDC, Legacy NDC, 1 package rows | 20241222_5305a38e-d9c8-4f9e-bf67-b246abc82cb1.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1992303 | timolol 0.5 % 12HR Ophthalmic Solution | PSN | 5305a38e-d9c8-4f9e-bf67-b246abc82cb1 | 5 |
| 1992303 | 12 HR timolol 5 MG/ML Ophthalmic Solution | SCD | 5305a38e-d9c8-4f9e-bf67-b246abc82cb1 | 5 |
| 1992303 | timolol 0.5 % (as timolol maleate 6.8 MG/ML) 12 HR Ophthalmic Solution | SY | 5305a38e-d9c8-4f9e-bf67-b246abc82cb1 | 5 |
| 1992303 | timolol 0.5 % 12 HR Ophthalmic Solution | SY | 5305a38e-d9c8-4f9e-bf67-b246abc82cb1 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-3441-0 | 50090344100 | 10 mL in 1 BOTTLE, PLASTIC (50090-3441-0) | 10 ml | 2018-04-20 | 0000-00-00 | No | No | Current |