Fluocinolone Acetonide
- Product NDC
- 0168-0059
- 11-digit product format
- 001680059
- Labeler code
- 0168
- Product ID
- 0168-0059_7c4e6b9b-d444-4afe-a658-cdb4a6205ad2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluocinolone acetonide
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Fougera Pharmaceuticals, LLC
- Application
- ANDA088167
- Marketing category
- ANDA
- Marketing start
- 1982-12-16
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .1 mg/mL
- 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 | .1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0CD5FD6S2M |
| Rxcui | 1191310 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0168-0059-60 | Fluocinolone Acetonide | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 10 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| fluocinolone acetonide | ACTIVE INGREDIENT | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE SOLUTION [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| fluocinolone acetonide | ACTIVE MOIETY | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE SOLUTION [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | FLUOCINOLONE ACETONIDE SOLUTION [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUOCINOLONE ACETONIDE SOLUTION [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 6 | |
| FLUOCINOLONE ACETONIDE | ACTIVE INGREDIENT | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| FLUOCINOLONE ACETONIDE | ACTIVE MOIETY | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | FLUOCINOLONE ACETONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUOCINOLONE ACETONIDE SOLUTION [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0168-0059 | FLUOCINOLONE ACETONIDE SOLUTION [FOUGERA PHARMACEUTICALS INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20231206_5649e15a-6a7c-4752-ac28-01e453afb37e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0168-0059-60 | 00168005960 | 60 mL in 1 BOTTLE (0168-0059-60) | 60 ml | 1982-12-16 | 0000-00-00 | No | No | Current |