Dorzolamide Hydrochloride and Timolol Maleate
- Product NDC
- 50383-233
- 11-digit product format
- 503830233
- Labeler code
- 50383
- Product ID
- 50383-233_d893628a-2d64-464a-b948-2abfafdf83c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide Hydrochloride and Timolol Maleate
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Akorn
- Application
- ANDA077847
- Marketing category
- ANDA
- Marketing start
- 2008-10-28
- Marketing end
- 0000-00-00
- Substance
- DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
- Active strength
- 20 mg/mL; mg/mL
- Pharmacologic classes
- Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50383-233-05 | Dorzolamide Hydrochloride and Timolol Maleate | 1 in 1 BOX | SOLUTION/ DROPS | 1 | | 14 |
| 50383-233-05 | Dorzolamide Hydrochloride and Timolol Maleate | 5 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 5 | | 14 |
| 50383-233-10 | Dorzolamide Hydrochloride and Timolol Maleate | 1 in 1 BOX | SOLUTION/ DROPS | 1 | | 14 |
| 50383-233-10 | Dorzolamide Hydrochloride and Timolol Maleate | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DORZOLAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | QZO5366EW7 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| TIMOLOL MALEATE | ACTIVE INGREDIENT | P8Y54F701R | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| DORZOLAMIDE | ACTIVE MOIETY | 9JDX055TW1 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| TIMOLOL ANHYDROUS | ACTIVE MOIETY | 5JKY92S7BR | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [HI-TECH PHARMACAL CO., INC.] | 6 | |
| DORZOLAMIDE HYDROCHLORIDE | ACTIVE INGREDIENT | QZO5366EW7 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TIMOLOL MALEATE | ACTIVE INGREDIENT | P8Y54F701R | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| DORZOLAMIDE | ACTIVE MOIETY | 9JDX055TW1 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| TIMOLOL | ACTIVE MOIETY | 817W3C6175 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) | INACTIVE INGREDIENT | S38J6RZN16 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50383-233 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE SOLUTION/ DROPS [AKORN] | 14 | Legacy NDC, 4 package rows | 20220602_2a236f05-1ee1-4180-9d80-31518d2204c7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50383-233-05 | 50383023305 | 1 BOTTLE, DROPPER in 1 BOX (50383-233-05) > 5 mL in 1 BOTTLE, DROPPER | 2009-10-28 | 0000-00-00 | No | No | Current |
| 50383-233-10 | 50383023310 | 1 BOTTLE, DROPPER in 1 BOX (50383-233-10) > 10 mL in 1 BOTTLE, DROPPER | 2009-10-28 | 0000-00-00 | No | No | Current |