timolol maleate ophthalmic gel forming solution
- Product NDC
- 68083-457
- 11-digit product format
- 680830457
- Labeler code
- 68083
- Product ID
- 68083-457_0c73f98d-4f49-415a-abc5-2d253061e669
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- timolol maleate ophthalmic gel forming solution
- Dosage form
- SOLUTION, GEL FORMING / DROPS
- Route
- OPHTHALMIC
- Labeler
- Gland Pharma Limited
- Application
- ANDA214645
- Marketing category
- ANDA
- Marketing start
- 2022-06-24
- 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 ophthalmic gel forming solution
- 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 | 313407, 313408 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-457-01 | timolol maleate ophthalmic gel forming solution | 1 in 1 CARTON | SOLUTION, GEL FORMING / DROPS | 1 | | 4 |
| 68083-457-01 | timolol maleate ophthalmic gel forming solution | 5 mL in 1 BOTTLE | SOLUTION, GEL FORMING / DROPS | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-457 | TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION SOLUTION, GEL FORMING / DROPS TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION (TIMOLOL MALEATE OPHTHALMIC GEL FORMING) SOLUTION, GEL FORMING / DROPS [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20230217_79730e4f-d533-42c7-b7b6-cdbc47242baa.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 |
|---|
| 68083-457-01 | 68083045701 | 1 BOTTLE in 1 CARTON (68083-457-01) / 5 mL in 1 BOTTLE | 1 bottle | 2022-06-24 | 0000-00-00 | No | No | Current |