Dorzolamide Hydrochloride and Timolol Maleate Preservative Free
- Product NDC
- 65862-947
- 11-digit product format
- 658620947
- Labeler code
- 65862
- Product ID
- 65862-947_62486059-bf52-4bd3-b902-a1423c9bf649
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide Hydrochloride and Timolol Maleate Preservative Free
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA207630
- Marketing category
- ANDA
- Marketing start
- 2018-07-24
- Substance
- DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
- Active strength
- 20; 5 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Dorzolamide Hydrochloride and Timolol Maleate Preservative Free
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DORZOLAMIDE HYDROCHLORIDE | 20 mg/mL |
| TIMOLOL MALEATE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QZO5366EW7, P8Y54F701R |
| Rxcui | 1922783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-947-15 | Dorzolamide Hydrochloride and Timolol Maleate Preservative Free | 0.2 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 0.2 | | 3 |
| 65862-947-15 | Dorzolamide Hydrochloride and Timolol Maleate Preservative Free | 15 in 1 POUCH | SOLUTION/ DROPS | 15 | | 3 |
| 65862-947-18 | Dorzolamide Hydrochloride and Timolol Maleate Preservative Free | 15 in 1 POUCH | SOLUTION/ DROPS | 15 | | 3 |
| 65862-947-18 | Dorzolamide Hydrochloride and Timolol Maleate Preservative Free | 12 in 1 CARTON | SOLUTION/ DROPS | 12 | | 3 |
| 65862-947-60 | Dorzolamide Hydrochloride and Timolol Maleate Preservative Free | 4 in 1 CARTON | SOLUTION/ DROPS | 4 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-947 | DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE SOLUTION/ DROPS [AUROBINDO PHARMA LIMITED] | 2 | Current NDC, Legacy NDC, 5 package rows | 20230823_f41a9cd5-48c8-42eb-bb1b-d0355d981201.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 |
|---|
| 65862-947-15 | 65862094715 | 0.2 mL in 1 VIAL, SINGLE-USE | 0.2 ml | | | | | Historical |
| 65862-947-18 | 65862094718 | 12 POUCH in 1 CARTON (65862-947-18) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USE | 12 pouch | 2018-07-24 | 0000-00-00 | No | No | Current |
| 65862-947-60 | 65862094760 | 4 POUCH in 1 CARTON (65862-947-60) / 15 VIAL, SINGLE-USE in 1 POUCH (65862-947-15) / .2 mL in 1 VIAL, SINGLE-USE | 4 pouch | 2018-07-24 | 0000-00-00 | No | No | Current |