Fluocinolone Acetonide Topical Solution USP, 0.01%
- Product NDC
- 21922-003
- 11-digit product format
- 219220003
- Labeler code
- 21922
- Product ID
- 21922-003_2a5cbd76-85fe-4c9c-89b9-7c5924c82c6f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinolone Acetonide Topical Solution USP, 0.01%
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA209913
- Marketing category
- ANDA
- Marketing start
- 2019-03-20
- 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 Topical Solution USP, 0.01%
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21922-003-01 | Fluocinolone Acetonide Topical Solution USP, 0.01% | 60 mL in 1 BOTTLE | SOLUTION | 60 | | 6 |
| 21922-003-01 | Fluocinolone Acetonide Topical Solution USP, 0.01% | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-003 | FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% SOLUTION [ENCUBE ETHICALS PRIVATE LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240316_3fb00d90-6a5b-4e95-ab6b-f5b102ff0f36.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 |
|---|
| 21922-003-01 | 21922000301 | 1 BOTTLE in 1 CARTON (21922-003-01) / 60 mL in 1 BOTTLE | 1 bottle | 2019-03-20 | 0000-00-00 | No | No | Current |