Dorzolamide and Timolol
- Product NDC
- 69315-305
- 11-digit product format
- 693150305
- Labeler code
- 69315
- Product ID
- 69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Leading Pharma, LLC
- Application
- ANDA205295
- Marketing category
- ANDA
- Marketing start
- 2017-05-18
- Substance
- DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
- Active strength
- 20; 5 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [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
- Dorzolamide and Timolol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DORZOLAMIDE HYDROCHLORIDE | 20 mg/mL |
| TIMOLOL MALEATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QZO5366EW7, P8Y54F701R |
| Rxcui | 1923432 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69315-305-05 | Dorzolamide and Timolol | 1 in 1 CARTON | SOLUTION | 1 | | 7 |
| 69315-305-05 | Dorzolamide and Timolol | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | | 7 |
| 69315-305-10 | Dorzolamide and Timolol | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | | 7 |
| 69315-305-10 | Dorzolamide and Timolol | 1 in 1 CARTON | SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69315-305 | DORZOLAMIDE AND TIMOLOL (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE OPHTHALMIC SOLUTION) SOLUTION [LEADING PHARMA, LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240526_c9ae08c5-275d-44b3-9d1e-5d8fedc21b96.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 |
|---|
| 69315-305-05 | 69315030505 | 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTIC | 2017-05-18 | 0000-00-00 | No | No | Current |
| 69315-305-10 | 69315030510 | 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTIC | 2017-05-18 | 0000-00-00 | No | No | Current |