Fluocinonide
- Product NDC
- 52565-029
- 11-digit product format
- 525650029
- Labeler code
- 52565
- Product ID
- 52565-029_f032f8fd-f723-4b97-8756-73d6eec936fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Teligent Pharma, Inc.
- Application
- ANDA211410
- Marketing category
- ANDA
- Marketing start
- 2018-10-16
- Marketing end
- 0000-00-00
- Substance
- FLUOCINONIDE
- Active strength
- 1 mg/g
- 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 |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| a338afdd-91bc-4c45-5113-8b445b8e6cf2 | Product name | 5 | 20200618 |
| f3bf4e6e-291f-4372-8e90-b4047949153a | Product name | 3 | 20200514 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 934e8c63-e34a-6dfb-4224-efad2d76fafc | Product name | 5 | 20190405 |
| ac5b31c4-5bd3-4df8-8f07-dbc9d194cdfe | Product name | 1 | 20181219 |
| ef1d202f-16bf-4f17-a390-087db27f5314 | Product name | 1 | 20181203 |
| de14082b-1b4a-48ac-b75c-4ee3ff8a29be | Product name | 1 | 20180809 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52565-029-11 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8349-a426-e053-dadaa90af4c2 | Fluocinonide Cream USP, 0.05% |
| 52565-029-15 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8349-a426-e053-dadaa90af4c2 | Fluocinonide Cream USP, 0.05% |
| 52565-029-30 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8349-a426-e053-dadaa90af4c2 | Fluocinonide Cream USP, 0.05% |
| 52565-029-60 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-8349-a426-e053-dadaa90af4c2 | Fluocinonide Cream USP, 0.05% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 52565-029-11 | Fluocinonide | 120 g in 1 TUBE | CREAM | 120 | 1 | |
| 52565-029-11 | Fluocinonide | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 52565-029-15 | Fluocinonide | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 52565-029-15 | Fluocinonide | 15 g in 1 TUBE | CREAM | 15 | 1 | |
| 52565-029-30 | Fluocinonide | 30 g in 1 TUBE | CREAM | 30 | 1 | |
| 52565-029-30 | Fluocinonide | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 52565-029-60 | Fluocinonide | 1 in 1 CARTON | CREAM | 1 | 1 | |
| 52565-029-60 | Fluocinonide | 60 g in 1 TUBE | CREAM | 60 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | 22c63641-b0cf-4064-9182-8481f746edf3 | 1 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | 22c63641-b0cf-4064-9182-8481f746edf3 | 1 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | 22c63641-b0cf-4064-9182-8481f746edf3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 52565-029-11 | 52565002911 | 1 TUBE in 1 CARTON (52565-029-11) > 120 g in 1 TUBE | 1 tube | 2018-10-16 | 0000-00-00 | No | No | Current |
| 52565-029-15 | 52565002915 | 1 TUBE in 1 CARTON (52565-029-15) > 15 g in 1 TUBE | 1 tube | 2018-10-16 | 0000-00-00 | No | No | Current |
| 52565-029-30 | 52565002930 | 1 TUBE in 1 CARTON (52565-029-30) > 30 g in 1 TUBE | 1 tube | 2018-10-16 | 0000-00-00 | No | No | Current |
| 52565-029-60 | 52565002960 | 1 TUBE in 1 CARTON (52565-029-60) > 60 g in 1 TUBE | 1 tube | 2018-10-16 | 0000-00-00 | No | No | Current |