DORZOLAMIDE HYDROCHLORIDE
- Product NDC
- 61314-019
- 11-digit product format
- 613140019
- Labeler code
- 61314
- Product ID
- 61314-019_764fec18-11c4-4320-a834-83c80c7040d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dorzolamide hydrochloride
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- ANDA078981
- Marketing category
- ANDA
- Marketing start
- 2009-06-01
- 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 973dd458-49b1-1bb1-62c6-b37c4b15fe1f | Product name | 5 | 20251121 |
| 03f77cb2-b4ad-3c11-8781-787b5ece4291 | Product name | 3 | 20240507 |
| 97dad5a2-c524-a7b5-dede-82edefe9ce62 | Product name | 7 | 20220929 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61314-019-05 | DORZOLAMIDE HYDROCHLORIDE | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | 15 | |
| 61314-019-10 | DORZOLAMIDE HYDROCHLORIDE | 10 mL in 1 BOTTLE | SOLUTION/ DROPS | 10 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61314-019-10 | ML - Milliliter | 61314-019 | 28707815-1adb-4b16-846c-9253d7d3fee7 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| DORZOLAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | QZO5366EW7 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.] | 9 | |
| DORZOLAMIDE | ACTIVE MOIETY | 9JDX055TW1 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.] | 9 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.] | 9 | |
| Hydroxyethyl Cellulose (2000 Cps At 1%) | INACTIVE INGREDIENT | S38J6RZN16 | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.] | 9 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.] | 9 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.] | 9 | |
| Trisodium Citrate Dihydrate | INACTIVE INGREDIENT | B22547B95K | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DORZOLAMIDE HYDROCHLORIDE SOLUTION/ DROPS [SANDOZ INC.] | 9 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 310015 | dorzolamide HCl 2 % Ophthalmic Solution | PSN | 29157995-fa61-4425-86a5-5bd0e4718cd8 | 15 |
| 310015 | dorzolamide 20 MG/ML Ophthalmic Solution | SCD | 29157995-fa61-4425-86a5-5bd0e4718cd8 | 15 |
| 310015 | dorzolamide 2 % Ophthalmic Solution | SY | 29157995-fa61-4425-86a5-5bd0e4718cd8 | 15 |
| 310015 | dorzolamide 20 MG/ML (as dorzolamide HCl 22.3 MG/ML) Ophthalmic Solution | SY | 29157995-fa61-4425-86a5-5bd0e4718cd8 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61314-019-05 | 61314001905 | 5 mL in 1 BOTTLE | 5 ml | Historical | ||||
| 61314-019-10 | 61314001910 | 10 mL in 1 BOTTLE (61314-019-10) | 10 ml | 2009-06-01 | 0000-00-00 | No | No | Current |