Timolol Maleate
- Product NDC
- 17478-288
- 11-digit product format
- 174780288
- Labeler code
- 17478
- Product ID
- 17478-288_f060b454-1334-42d7-ad91-266f34581ce8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Timolol Maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA074466
- Marketing category
- ANDA
- Marketing start
- 2012-03-26
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 17478-288-10 | Timolol Maleate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 10 |
| 17478-288-10 | Timolol Maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 10 |
| 17478-288-11 | Timolol Maleate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 10 |
| 17478-288-11 | Timolol Maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 10 |
| 17478-288-12 | Timolol Maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 10 |
| 17478-288-12 | Timolol Maleate | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | | 10 |
| 17478-288-25 | Timolol Maleate | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 10 |
| 17478-288-25 | Timolol Maleate | 2.5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 2.5 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Timolol Maleate | ACTIVE INGREDIENT | P8Y54F701R | TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.] | 4 | |
| Timolol Anhydrous | ACTIVE MOIETY | 5JKY92S7BR | TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.] | 4 | |
| Benzalkonium Chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.] | 4 | |
| Sodium Hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.] | 4 | |
| Sodium Phosphate, Dibasic | INACTIVE INGREDIENT | GR686LBA74 | TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.] | 4 | |
| Sodium Phosphate, Monobasic | INACTIVE INGREDIENT | 3980JIH2SW | TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.] | 4 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | TIMOLOL MALEATE SOLUTION/ DROPS [AKORN, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17478-288 | TIMOLOL MALEATE SOLUTION/ DROPS [AKORN] | 10 | Legacy NDC, 8 package rows | 20220524_c9726422-f794-4d39-a437-17dcb8c0f3b5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17478-288-10 | 17478028810 | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-10) > 5 mL in 1 BOTTLE, DROPPER | 2012-03-26 | 0000-00-00 | No | No | Current |
| 17478-288-11 | 17478028811 | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-11) > 10 mL in 1 BOTTLE, DROPPER | 2012-03-26 | 0000-00-00 | No | No | Current |
| 17478-288-12 | 17478028812 | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-12) > 15 mL in 1 BOTTLE, DROPPER | 2012-03-26 | 0000-00-00 | No | No | Current |
| 17478-288-25 | 17478028825 | 1 BOTTLE, DROPPER in 1 CARTON (17478-288-25) > 2.5 mL in 1 BOTTLE, DROPPER | 2012-03-26 | 0000-00-00 | No | No | Current |