Difluprednate Ophthalmic
- Product NDC
- 0781-6000
- 11-digit product format
- 007816000
- Labeler code
- 0781
- Product ID
- 0781-6000_6ae7a5b2-4844-4a63-a95e-8dd76c1e3653
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Difluprednate Ophthalmic
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Sandoz Inc
- Application
- NDA022212
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2013-05-15
- 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
- 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 |
|---|
| 0781-6000-78 | Difluprednate Ophthalmic | 1 in 1 CARTON | EMULSION | 1 | | 4 |
| 0781-6000-78 | Difluprednate Ophthalmic | 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 |
|---|
| 0781-6000 | DIFLUPREDNATE OPHTHALMIC EMULSION [SANDOZ INC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20220702_0f60b857-7898-4a9e-935c-a9ddf0eb9194.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 |
|---|
| 0781-6000-78 | 00781600078 | 1 BOTTLE in 1 CARTON (0781-6000-78) / 5 mL in 1 BOTTLE | 1 bottle | 2021-09-15 | 0000-00-00 | No | No | Current |