Dorzolamide hydrochloride
- Product NDC
- 55545-1008
- 11-digit product format
- 555451008
- Labeler code
- 55545
- Product ID
- 55545-1008_97618f4f-5891-0f06-e053-2995a90a3122
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide hydrochloride
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- FDC Limited
- Application
- ANDA205294
- Marketing category
- ANDA
- Marketing start
- 2019-11-16
- Marketing end
- 0000-00-00
- Substance
- DORZOLAMIDE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA]
- 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 |
|---|
| 55545-1008-1 | Dorzolamide hydrochloride | 5 mL in 1 BOTTLE | SOLUTION | 5 | | 2 |
| 55545-1008-1 | Dorzolamide hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
| 55545-1008-2 | Dorzolamide hydrochloride | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 2 |
| 55545-1008-2 | Dorzolamide hydrochloride | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55545-1008 | DORZOLAMIDE HYDROCHLORIDE SOLUTION [FDC LIMITED] | 2 | Legacy NDC, 4 package rows | 20191116_751ced94-0ba7-46d8-b560-b9de57802284.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 55545-1008-1 | 55545100801 | 5 mL in 1 BOTTLE | 5 ml | Historical |
| 55545-1008-2 | 55545100802 | 10 mL in 1 BOTTLE | 10 ml | Historical |