YUTIQ
- Product NDC
- 68611-180
- 11-digit product format
- 686110180
- Labeler code
- 68611
- Product ID
- 68611-180_f684c980-0cfe-11f1-b4ac-0800200c9a66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUOCINOLONE ACETONIDE
- Dosage form
- IMPLANT
- Route
- INTRAVITREAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA210331
- Marketing category
- NDA
- Marketing start
- 2023-05-17
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .18 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- YUTIQ
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOCINOLONE ACETONIDE | .18 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0CD5FD6S2M |
| Rxcui | 2099361, 2099366 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68611-180-01 | YUTIQ | 1 in 1 POUCH | IMPLANT | 1 | | 4 |
| 68611-180-01 | YUTIQ | 1 in 1 CARTON | IMPLANT | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68611-180 | YUTIQ (FLUOCINOLONE ACETONIDE) IMPLANT [ALIMERA SCIENCES, INC.] | 3 | Current NDC, 2 package rows | 20241205_f270cad8-ed82-4969-b785-831a1910bfa6.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 |
|---|
| 68611-180-01 | 68611018001 | 1 POUCH in 1 CARTON (68611-180-01) / 1 APPLICATOR in 1 POUCH / 1 IMPLANT in 1 APPLICATOR | 1 pouch | 2023-05-17 | No | No | Historical |