Fluocinolone Acetonide
- Product NDC
- 52565-012
- 11-digit product format
- 525650012
- Labeler code
- 52565
- Product ID
- 52565-012_088e8303-2f51-470d-86ec-dcfcee267650
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinolone Acetonide
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- Teligent Pharma, Inc.
- Application
- NDA015296
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2012-11-27
- Marketing end
- 0000-00-00
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- 0 mg/mL
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0adb2af5-1ecf-4df5-912b-16ae89228294 | Product name | 6 | 20240829 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 65f6255d-41cc-425f-ba54-b1bea4947886 | Product name | 5 | 20210930 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 5ba208e4-886f-44da-e218-ab4f4cad2c49 | Product name | 5 | 20190612 |
| e5a2793f-318b-72fd-b734-c44ecc6f6748 | Product name | 2 | 20190213 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 9e453f34-aacb-44d5-a119-c0e3dc1fca2a | Product name | 1 | 20160622 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 7df2570a-c555-4d82-9189-9247c722b62c | Product name | 1 | 20150402 |
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
| a78a3633-fd06-b0af-63b3-c714de3b3bfa | Product name | 1 | 20140508 |
| b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52565-012-59 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6940-a426-e053-dadaa90af4c2 | Fluocinolone Acetonide Topical Solution USP, 0.01% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52565-012-59 | Fluocinolone Acetonide | 1 in 1 CARTON | SOLUTION | 1 | 5 | |
| 52565-012-59 | Fluocinolone Acetonide | 60 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 60 | 5 | |
| 52565-012-59 | NOXIPAK | 1 in 1 CARTON | SOLUTION | 0.1 mg in 1mL | 2 | |
| 52565-012-59 | NOXIPAK | 60 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 60 mL | 0.1 mg in 1mL | 2 |
| 52565-012-59 | XILAPAK | 60 mL in 1 BOTTLE, WITH APPLICATOR | SOLUTION | 60 mL | 0.1 mg in 1mL | 1 |
| 52565-012-59 | XILAPAK | 1 in 1 CARTON | SOLUTION | 0.1 mg in 1mL | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52565-012-59 | ML - Milliliter | 52565-012 | e73c8061-3edf-4c0e-93f3-e4144c8853bc | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Fluocinolone Acetonide | ACTIVE INGREDIENT | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.] | 3 | |
| Fluocinolone Acetonide | ACTIVE MOIETY | 0CD5FD6S2M | FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.] | 3 | |
| Anhydrous Citric Acid | INACTIVE INGREDIENT | XF417D3PSL | FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.] | 3 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.] | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 52565-012 | FLUOCINOLONE ACETONIDE SOLUTION [TELIGENT PHARMA, INC.] | 5 | Legacy NDC, 2 package rows | 20181017_b859bc63-a9e3-4a6d-a3f7-711b4eeaba63.zip |
| 52565-012 | NOXIPAK (FLUOCINOLONE ACETONIDE AND UREA) KIT [SOLUTECH PHARMACEUTICALS LLC] | 2 | Legacy NDC | 20171109_136cb37e-e939-40b5-9725-194b14a9b090.zip |
| 52565-012 | XILAPAK (FLUOCINOLONE ACETONIDE) KIT [SOLUTECH PHARMACEUTICALS LLC] | 1 | Legacy NDC | 20171104_f1b8a26a-dc63-4701-8a78-cc1f99fca1b3.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1191310 | fluocinolone acetonide 0.01 % Topical Solution | PSN | b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 | 5 |
| 1191310 | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 | 5 |
| 1191310 | fluocinolone acetonide 0.01 % Topical Solution | SY | b859bc63-a9e3-4a6d-a3f7-711b4eeaba63 | 5 |
| 1191310 | fluocinolone acetonide 0.01 % Topical Solution | PSN | 136cb37e-e939-40b5-9725-194b14a9b090 | 2 |
| 198886 | urea 20 % Topical Cream | PSN | 136cb37e-e939-40b5-9725-194b14a9b090 | 2 |
| 1191310 | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | 136cb37e-e939-40b5-9725-194b14a9b090 | 2 |
| 198886 | urea 200 MG/ML Topical Cream | SCD | 136cb37e-e939-40b5-9725-194b14a9b090 | 2 |
| 1191310 | fluocinolone acetonide 0.01 % Topical Solution | SY | 136cb37e-e939-40b5-9725-194b14a9b090 | 2 |
| 198886 | urea 17 GM in 85 GM Topical Cream | SY | 136cb37e-e939-40b5-9725-194b14a9b090 | 2 |
| 198886 | urea 20 % Topical Cream | SY | 136cb37e-e939-40b5-9725-194b14a9b090 | 2 |
| 1191310 | fluocinolone acetonide 0.01 % Topical Solution | PSN | f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 | 1 |
| 1191310 | fluocinolone acetonide 0.1 MG/ML Topical Solution | SCD | f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 | 1 |
| 1191310 | fluocinolone acetonide 0.01 % Topical Solution | SY | f1b8a26a-dc63-4701-8a78-cc1f99fca1b3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 52565-012-59 | 52565001259 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52565-012-59) > 60 mL in 1 BOTTLE, WITH APPLICATOR | 2012-12-07 | 0000-00-00 | No | No | Current |