Fluocinolone Acetonide
- Product NDC
- 43386-069
- 11-digit product format
- 433860069
- Labeler code
- 43386
- Product ID
- 43386-069_15764733-88e0-40bf-ac92-ff4e3e35b15d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinolone Acetonide
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA206422
- Marketing category
- ANDA
- Marketing start
- 2015-09-02
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- .1 mg/mL
- 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 | .1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0CD5FD6S2M |
| Rxcui | 1191310 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-069-60 | Fluocinolone Acetonide | 1 in 1 CARTON | SOLUTION | 1 | | 5 |
| 43386-069-60 | Fluocinolone Acetonide | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-069 | FLUOCINOLONE ACETONIDE SOLUTION [LUPIN PHARMACEUTICALS,INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20190222_460f5a55-6437-4651-bc08-8063ca579c8d.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 |
|---|
| 43386-069-60 | 43386006960 | 1 BOTTLE in 1 CARTON (43386-069-60) / 60 mL in 1 BOTTLE | 1 bottle | 2015-09-02 | 0000-00-00 | No | No | Current |