Timolol Maleate
- Product NDC
- 61314-226
- 11-digit product format
- 613140226
- Labeler code
- 61314
- Product ID
- 61314-226_d1f4cdca-5a1b-4eb3-8b00-fa7d778bb1c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA074261
- Marketing category
- ANDA
- Marketing start
- 1996-01-15
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Timolol Maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TIMOLOL MALEATE | 2.5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | P8Y54F701R |
| Rxcui | 1923428, 1992303 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 61314-226-05 | 2024-08-16 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 61314-226-10 | 2024-08-16 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 61314-226-15 | 2024-08-16 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 61314-226-05 | 2024-07-30 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 61314-226-10 | 2024-07-30 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 61314-226-15 | 2024-07-30 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 61314-226-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 61314-226-10 | 2024-01-30 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
| 61314-226-15 | 2024-01-30 | C162847 | 48780-1 | 1030e365-48b5-111a-e063-dadaa90a10e2 | Timolol Maleate Ophthalmic Solution, USP 0.25% and 0.5% STERILE Rx Only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61314-226-05 | Timolol Maleate | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | | 9 |
| 61314-226-10 | Timolol Maleate | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | | 9 |
| 61314-226-15 | Timolol Maleate | 15 mL in 1 BOTTLE, PLASTIC | SOLUTION | 15 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TIMOLOL MALEATE | ACTIVE INGREDIENT | P8Y54F701R | TIMOLOL MALEATE SOLUTION [SANDOZ INC] | 3 | |
| TIMOLOL ANHYDROUS | ACTIVE MOIETY | 5JKY92S7BR | TIMOLOL MALEATE SOLUTION [SANDOZ INC] | 3 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | TIMOLOL MALEATE SOLUTION [SANDOZ INC] | 3 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TIMOLOL MALEATE SOLUTION [SANDOZ INC] | 3 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | TIMOLOL MALEATE SOLUTION [SANDOZ INC] | 3 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | TIMOLOL MALEATE SOLUTION [SANDOZ INC] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TIMOLOL MALEATE SOLUTION [SANDOZ INC] | 3 | |
| TIMOLOL MALEATE | ACTIVE INGREDIENT | P8Y54F701R | TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TIMOLOL ANHYDROUS | ACTIVE MOIETY | 5JKY92S7BR | TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM PHOSPHATE, DIBASIC | INACTIVE INGREDIENT | GR686LBA74 | TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM PHOSPHATE, MONOBASIC | INACTIVE INGREDIENT | 3980JIH2SW | TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | TIMOLOL MALEATE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61314-226 | TIMOLOL MALEATE SOLUTION [SANDOZ INC] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240817_f949fa34-6a9a-40d5-91ab-ff1cbb79b9ea.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61314-226-05 | 61314022605 | 5 mL in 1 BOTTLE, PLASTIC (61314-226-05) | 5 ml | 1996-01-15 | 0000-00-00 | No | No | Current |
| 61314-226-10 | 61314022610 | 10 mL in 1 BOTTLE, PLASTIC (61314-226-10) | 10 ml | 1996-01-15 | 0000-00-00 | No | No | Current |
| 61314-226-15 | 61314022615 | 15 mL in 1 BOTTLE, PLASTIC (61314-226-15) | 15 ml | 1996-01-15 | 0000-00-00 | No | No | Current |