Dorzolamide Hydrochloride Ophthalmic
- Product NDC
- 71921-400
- 11-digit product format
- 719210400
- Labeler code
- 71921
- Product ID
- 71921-400_e4e6a5a8-f7be-4424-83f2-d6bb4d57443e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide Hydrochloride Ophthalmic
- Dosage form
- SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Florida Pharmaceutical Products, LLC
- Application
- ANDA202053
- Marketing category
- ANDA
- Marketing start
- 2025-05-07
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dorzolamide Hydrochloride Ophthalmic
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DORZOLAMIDE HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QZO5366EW7 |
| Rxcui | 310015 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71921-400-10 | Dorzolamide Hydrochloride Ophthalmic | 10 mL in 1 BOTTLE | SOLUTION | 10 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71921-400-10 | 71921040010 | 10 mL in 1 BOTTLE (71921-400-10) | 10 ml | 2025-05-07 | No | No | Historical |