Difluprednate
- Product NDC
- 62332-750
- 11-digit product format
- 623320750
- Labeler code
- 62332
- Product ID
- 62332-750_2bc3d828-ffee-4526-a169-fb2bd39f0b7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- difluprednate ophthalmic
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA213774
- Marketing category
- ANDA
- Marketing start
- 2026-01-26
- Substance
- DIFLUPREDNATE
- Active strength
- .5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Difluprednate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIFLUPREDNATE | .5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | S8A06QG2QE |
| Rxcui | 804544 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62332-750-05 | Difluprednate | 5 mL in 1 BOTTLE | EMULSION | 5 | | 5 |
| 62332-750-05 | Difluprednate | 1 in 1 CARTON | EMULSION | 1 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 62332-750-05 | 62332075005 | 1 BOTTLE in 1 CARTON (62332-750-05) / 5 mL in 1 BOTTLE | 1 bottle | 2026-01-26 | No | No | Current |