Fluocinolone acetonide
- Product NDC
- 50090-7958
- 11-digit product format
- 500907958
- Labeler code
- 50090
- Product ID
- 50090-7958_af541048-b609-479d-83e8-d44de9f37941
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinolone acetonide
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202848
- Marketing category
- ANDA
- Marketing start
- 2017-06-14
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .01 mg/100mL
- 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
- Fluocinolone acetonide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUOCINOLONE ACETONIDE | .01 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0CD5FD6S2M |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-7958-0 | Fluocinolone acetonide | 1 in 1 CARTON | OIL | 1 | | 1 |
| 50090-7958-0 | Fluocinolone acetonide | 118.28 mL in 1 BOTTLE | OIL | 118.28 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-7958-0 | 50090795800 | 1 BOTTLE in 1 CARTON (50090-7958-0) / 118.28 mL in 1 BOTTLE | 1 bottle | 2026-05-04 | No | No | Historical |