Difluprednate
- Product NDC
- 65145-161
- 11-digit product format
- 651450161
- Labeler code
- 65145
- Product ID
- 65145-161_0f9a1987-6a04-4764-94e5-7053997c058b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Difluprednate
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Caplin Steriles Limited
- Application
- ANDA219441
- Marketing category
- ANDA
- Marketing start
- 2024-12-26
- 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
- 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 |
|---|
| 65145-161-01 | Difluprednate | 5 mL in 1 BOTTLE | EMULSION | 5 | | 1 |
| 65145-161-01 | Difluprednate | 1 in 1 CARTON | EMULSION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65145-161 | DIFLUPREDNATE EMULSION [CAPLIN STERILES LIMITED] | 1 | Current NDC, 2 package rows | 20241228_0f9a1987-6a04-4764-94e5-7053997c058b.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 |
|---|
| 65145-161-01 | 65145016101 | 1 BOTTLE in 1 CARTON (65145-161-01) / 5 mL in 1 BOTTLE | 1 bottle | 2024-12-26 | No | No | Current |