Dorzolamide Hydrochloride
- Product NDC
- 50383-232
- 11-digit product format
- 503830232
- Labeler code
- 50383
- Product ID
- 50383-232_25b2685a-bf28-4fc0-9956-27d5e1348bc1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide Hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA077846
- Marketing category
- ANDA
- Marketing start
- 2008-10-28
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DORZOLAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | QZO5366EW7 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 7 | |
| DORZOLAMIDE | ACTIVE MOIETY | 9JDX055TW1 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 7 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 7 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 7 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 7 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 7 | |
| TRISODIUM CITRATE DIHYDRATE | INACTIVE INGREDIENT | B22547B95K | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 7 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-232 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [AKORN] | 12 | Legacy NDC | 20220602_95fe7c85-b0e1-420d-8128-fd9e7a1fed09.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 |
|---|
| 50383-232-05 | 50383023205 | 1 BOTTLE in 1 CARTON (50383-232-05) > 5 mL in 1 BOTTLE | 1 bottle | 2008-10-28 | 0000-00-00 | No | No | Current |
| 50383-232-10 | 50383023210 | 1 BOTTLE in 1 CARTON (50383-232-10) > 10 mL in 1 BOTTLE | 1 bottle | 2008-10-28 | 0000-00-00 | No | No | Current |