Dorzolamide Hydrochloride
- Product NDC
- 14445-404
- 11-digit product format
- 144450404
- Labeler code
- 14445
- Product ID
- 14445-404_746e0cc7-7ea7-4090-acb3-69de5fe85be3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dorzolamide
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Indoco Remedies Limited
- Application
- ANDA202053
- Marketing category
- ANDA
- Marketing start
- 2021-05-14
- 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
- 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 |
|---|
| 14445-404-10 | Dorzolamide Hydrochloride | 10 mL in 1 BOTTLE, DISPENSING | SOLUTION/ DROPS | 10 | | 5 |
| 14445-404-10 | Dorzolamide Hydrochloride | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14445-404 | DORZOLAMIDE HYDROCHLORIDE (DORZOLAMIDE) SOLUTION/ DROPS [INDOCO REMEDIES LIMITED ] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241122_462a61b2-1ec6-4d18-bc6b-fc03e027caa0.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 |
|---|
| 14445-404-10 | 14445040410 | 1 BOTTLE, DISPENSING in 1 CARTON (14445-404-10) / 10 mL in 1 BOTTLE, DISPENSING | 2021-05-14 | 0000-00-00 | No | No | Current |