Difluprednate
- Product NDC
- 69238-1380
- 11-digit product format
- 692381380
- Labeler code
- 69238
- Product ID
- 69238-1380_28d97e13-000b-4f82-b42e-206c923ab057
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Difluprednate ophthalmic
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA211526
- Marketing category
- ANDA
- Marketing start
- 2021-11-18
- 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 |
|---|
| 69238-1380-3 | Difluprednate | 5 mL in 1 BOTTLE | EMULSION | 5 | | 7 |
| 69238-1380-3 | Difluprednate | 1 in 1 CARTON | EMULSION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1380 | DIFLUPREDNATE (DIFLUPREDNATE OPHTHALMIC) EMULSION [AMNEAL PHARMACEUTICALS NY LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240711_3612ff2a-c4bf-4322-b5bc-e7b867575321.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 |
|---|
| 69238-1380-3 | 69238138003 | 1 BOTTLE in 1 CARTON (69238-1380-3) / 5 mL in 1 BOTTLE | 1 bottle | 2021-11-18 | 0000-00-00 | No | No | Current |