DUREZOL
- Product NDC
- 66758-086
- 11-digit product format
- 667580086
- Labeler code
- 66758
- Product ID
- 66758-086_4dadac60-2b25-486b-b716-86516821678c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- difluprednate
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- NDA022212
- Marketing category
- NDA
- Marketing start
- 2011-01-25
- Substance
- DIFLUPREDNATE
- Active strength
- .5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DUREZOL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIFLUPREDNATE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S8A06QG2QE |
| Rxcui | 804544, 804547 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66758-086-75 | DUREZOL | 1 in 1 CARTON | EMULSION | 1 | | 4 |
| 66758-086-75 | DUREZOL | 5 mL in 1 BOTTLE | EMULSION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66758-086 | DUREZOL (DIFLUPREDNATE) EMULSION [SANDOZ INC] | 1 | Current NDC, 2 package rows | 20241206_ea520a27-f569-4b31-8bad-a25ad54b2caa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 66758-086-75 | 66758008675 | 1 BOTTLE in 1 CARTON (66758-086-75) / 5 mL in 1 BOTTLE | 1 bottle | 2024-12-06 | No | No | Historical |