Fluocinonide
- Product NDC
- 51862-494
- 11-digit product format
- 518620494
- Labeler code
- 51862
- Product ID
- 51862-494_ee9c4d1d-f609-74ad-e053-2a95a90ad6d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Mayne Pharma
- Application
- ANDA073085
- Marketing category
- ANDA
- Marketing start
- 2016-10-01
- Marketing end
- 0000-00-00
- Substance
- FLUOCINONIDE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a338afdd-91bc-4c45-5113-8b445b8e6cf2 | Product name | 5 | 20200618 |
| f3bf4e6e-291f-4372-8e90-b4047949153a | Product name | 3 | 20200514 |
| 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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-494-15 | GM - Gram | 51862-494 | f8958951-bfbd-471e-b57d-dc4cc9c5ee89 | 1 | 2016-12-07 |
| 51862-494-30 | GM - Gram | 51862-494 | 48d51a50-27aa-4d57-8784-3c44b4c4542d | 1 | 2016-12-07 |
| 51862-494-60 | GM - Gram | 51862-494 | 8520606a-dc73-444f-9cb3-4ae63799021b | 1 | 2016-11-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | a61ad82a-1889-4f8a-9627-bc81196cfbc2 | 5 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | a61ad82a-1889-4f8a-9627-bc81196cfbc2 | 5 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | a61ad82a-1889-4f8a-9627-bc81196cfbc2 | 5 |
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | 749d0c98-c048-401c-b59e-2de9dc923af1 | 1 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | 749d0c98-c048-401c-b59e-2de9dc923af1 | 1 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | 749d0c98-c048-401c-b59e-2de9dc923af1 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51862-494-15 | 51862049415 | 1 TUBE in 1 CARTON (51862-494-15) > 15 g in 1 TUBE | 1 tube | 2016-10-01 | 0000-00-00 | No | No | Current |
| 51862-494-30 | 51862049430 | 1 TUBE in 1 CARTON (51862-494-30) > 30 g in 1 TUBE | 1 tube | 2016-10-01 | 0000-00-00 | No | No | Current |
| 51862-494-60 | 51862049460 | 1 TUBE in 1 CARTON (51862-494-60) > 60 g in 1 TUBE | 1 tube | 2016-10-01 | 0000-00-00 | No | No | Current |