fluocinolone acetonide
- Product NDC
- 72162-1434
- 11-digit product format
- 721621434
- Labeler code
- 72162
- Product ID
- 72162-1434_c4b24e65-1fe8-47bf-ba99-b81afcbbf2d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluocinolone acetonide
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202847
- 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 |
|---|
| 72162-1434-2 | fluocinolone acetonide | 1 in 1 CARTON | OIL | 1 | | 104 |
| 72162-1434-2 | fluocinolone acetonide | 118.28 mL in 1 BOTTLE | OIL | 118.28 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-1434 | FLUOCINOLONE ACETONIDE OIL [BRYANT RANCH PREPACK] | 103 | Current NDC, 2 package rows | 20250523_4790bdfa-c964-4c3e-9d01-c2fb23a0172e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-1434-2 | 72162143402 | 1 BOTTLE in 1 CARTON (72162-1434-2) / 118.28 mL in 1 BOTTLE | 1 bottle | 2024-03-12 | No | No | Current |