Timolol Maleate
- Product NDC
- 16571-223
- 11-digit product format
- 165710223
- Labeler code
- 16571
- Product ID
- 16571-223_ebb620d8-8e2e-4632-b8a8-74f41c9969e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA207556
- Marketing category
- ANDA
- Marketing start
- 2024-12-10
- Substance
- TIMOLOL MALEATE
- Active strength
- 5 mg/1
- 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 |
|---|---|---|---|---|---|---|
| 16571-223-01 | Timolol Maleate | 100 in 1 BOTTLE | TABLET | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16571-223-01 | EA - Each | 16571-223 | 1b2b525a-db5e-4dab-bd2c-5ae5ff3aeb78 | 1 | 2025-01-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198284 | timolol maleate 10 MG Oral Tablet | PSN | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
| 198285 | timolol maleate 20 MG Oral Tablet | PSN | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
| 198286 | timolol maleate 5 MG Oral Tablet | PSN | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
| 198284 | timolol 10 MG Oral Tablet | SCD | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
| 198285 | timolol 20 MG Oral Tablet | SCD | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
| 198286 | timolol 5 MG Oral Tablet | SCD | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
| 198284 | timolol 10 MG (as maleate) Oral Tablet | SY | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
| 198285 | timolol 20 MG (as maleate) Oral Tablet | SY | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
| 198286 | timolol 5 MG (as maleate) Oral Tablet | SY | 0bc40b2c-65eb-4095-87e6-4752d5b19a3a | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 16571-223-01 | 16571022301 | 100 TABLET in 1 BOTTLE (16571-223-01) | 100 tablet | 2024-12-10 | No | No | Historical |