TIMOLOL MALEATE
- Product NDC
- 60758-802
- 11-digit product format
- 607580802
- Labeler code
- 60758
- Product ID
- 60758-802_27ed7b7d-7640-4566-90f3-42a17a9d1a98
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- timolol maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Pacific Pharma, Inc.
- Application
- ANDA074746
- Marketing category
- ANDA
- Marketing start
- 1997-05-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TIMOLOL MALEATE
- Listing expiration
- 2027-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60758-802-05 | TIMOLOL MALEATE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 16 |
| 60758-802-05 | TIMOLOL MALEATE | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 16 |
| 60758-802-10 | TIMOLOL MALEATE | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 16 |
| 60758-802-10 | TIMOLOL MALEATE | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| timolol maleate | ACTIVE INGREDIENT | P8Y54F701R | TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] | 8 | |
| timolol anhydrous | ACTIVE MOIETY | 5JKY92S7BR | TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] | 8 | |
| benzalkonium chloride | INACTIVE INGREDIENT | F5UM2KM3W7 | TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] | 8 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] | 8 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] | 8 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] | 8 | |
| sodium phosphate, monobasic | INACTIVE INGREDIENT | 3980JIH2SW | TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] | 8 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | TIMOLOL MALEATE (TIMOLOL MALEATE) SOLUTION/ DROPS [PACIFIC PHARMA, INC.
] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60758-802 | TIMOLOL MALEATE SOLUTION/ DROPS [PACIFIC PHARMA, INC.] | 15 | Current NDC, Legacy NDC, 4 package rows | 20240404_e16c33fd-aa86-49ad-a767-c79ade4a62c7.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 |
|---|
| 60758-802-05 | 60758080205 | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-05) / 5 mL in 1 BOTTLE, DROPPER | 1997-05-20 | 0000-00-00 | No | No | Current |
| 60758-802-10 | 60758080210 | 1 BOTTLE, DROPPER in 1 CARTON (60758-802-10) / 10 mL in 1 BOTTLE, DROPPER | 1997-05-20 | 0000-00-00 | No | No | Current |