Fluocinolone acetonide
- Product NDC
- 45802-485
- 11-digit product format
- 458020485
- Labeler code
- 45802
- Product ID
- 45802-485_a42dc988-a62b-4c68-8736-f4a363ab4b35
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinolone acetonide
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluocinolone acetonide
- Listing expiration
- 2026-12-31
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 |
|---|
| 45802-485-26 | Fluocinolone acetonide | 1 in 1 CARTON | OIL | 1 | | 13 |
| 45802-485-26 | Fluocinolone acetonide | 118.28 mL in 1 BOTTLE | OIL | 118.28 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-485 | FLUOCINOLONE ACETONIDE OIL [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 12 | Current NDC, Legacy NDC, 2 package rows | 20250516_7f8512d9-b4a4-43c6-bac6-3e75dc451db2.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45802-485-26 | 45802048526 | 1 BOTTLE in 1 CARTON (45802-485-26) / 118.28 mL in 1 BOTTLE | 1 bottle | 2017-06-14 | 0000-00-00 | No | No | Current |