Dorzolamide and Timolol
- Product NDC
- 55545-1007
- 11-digit product format
- 555451007
- Labeler code
- 55545
- Product ID
- 55545-1007_97619b26-b0db-db63-e053-2995a90abdba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide Hydrochloride and Timolol Maleate
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- FDC Limited
- Application
- ANDA205295
- Marketing category
- ANDA
- Marketing start
- 2019-11-16
- Marketing end
- 0000-00-00
- Substance
- DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
- Active strength
- 20 mg/mL; mg/mL
- Pharmacologic classes
- Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55545-1007-1 | Dorzolamide and Timolol | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
| 55545-1007-1 | Dorzolamide and Timolol | 5 mL in 1 BOTTLE, PLASTIC | SOLUTION | 5 | | 1 |
| 55545-1007-2 | Dorzolamide and Timolol | 10 mL in 1 BOTTLE, PLASTIC | SOLUTION | 10 | | 1 |
| 55545-1007-2 | Dorzolamide and Timolol | 1 in 1 CARTON | SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55545-1007 | DORZOLAMIDE AND TIMOLOL (DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE) SOLUTION [FDC LIMITED] | 1 | Legacy NDC, 4 package rows | 20191116_3189b866-d8ba-4ffc-a51b-20a46ce9c361.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 55545-1007-1 | 55545100701 | 1 in 1 CARTON | | Historical |
| 55545-1007-2 | 55545100702 | 10 mL in 1 BOTTLE, PLASTIC | 10 ml | Historical |