Difluprednate Ophthalmic Emulsion
- Product NDC
- 43598-588
- 11-digit product format
- 435980588
- Labeler code
- 43598
- Product ID
- 43598-588_acd98bc6-dcd8-d0f5-9b9a-d2652e0c37c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Difluprednate Ophthalmic
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA214894
- Marketing category
- ANDA
- Marketing start
- 2022-12-25
- 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
- Difluprednate Ophthalmic Emulsion
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43598-588-11 | Difluprednate Ophthalmic Emulsion | 5 mL in 1 BOTTLE | EMULSION | 5 | | 6 |
| 43598-588-11 | Difluprednate Ophthalmic Emulsion | 1 in 1 CARTON | EMULSION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-588 | DIFLUPREDNATE OPHTHALMIC EMULSION (DIFLUPREDNATE OPHTHALMIC) EMULSION [DR. REDDY'S LABORATORIES INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250112_12803630-3196-1b3e-28e4-a598a742ef1a.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 |
|---|
| 43598-588-11 | 43598058811 | 1 BOTTLE in 1 CARTON (43598-588-11) / 5 mL in 1 BOTTLE | 1 bottle | 2022-12-25 | 0000-00-00 | No | No | Current |