Fluocinolone Acetonide
- Product NDC
- 51672-1357
- 11-digit product format
- 516721357
- Labeler code
- 51672
- Product ID
- 51672-1357_3dd48727-c9ec-69b5-e063-6294a90a3c31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinolone Acetonide
- Dosage form
- OIL
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA209336
- Marketing category
- ANDA
- Marketing start
- 2016-05-19
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .11 mg/118.28mL
- 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 | .11 mg/118.28mL |
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 |
|---|
| 51672-1357-8 | Fluocinolone Acetonide | 118.28 mL in 1 BOTTLE | OIL | 118.28 | | 15 |
| 51672-1357-8 | Fluocinolone Acetonide | 1 in 1 CARTON | OIL | 1 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-1357 | FLUOCINOLONE ACETONIDE OIL [TARO PHARMACEUTICALS U.S.A., INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241222_b6796a10-9c90-429d-bfd6-33b557dc952c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-1357-8 | 51672135708 | 1 BOTTLE in 1 CARTON (51672-1357-8) / 118.28 mL in 1 BOTTLE | 1 bottle | 2016-05-19 | 0000-00-00 | No | No | Current |