Fluocinonide
- Product NDC
- 0168-0139
- 11-digit product format
- 001680139
- Labeler code
- 0168
- Product ID
- 0168-0139_968a1e44-77ad-4680-aa7e-46178d59181d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluocinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA073030
- Marketing category
- ANDA
- Marketing start
- 1994-10-17
- Marketing end
- 2021-04-30
- Substance
- FLUOCINONIDE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|---|---|---|---|---|
| 0168-0139-15 | GM - Gram | 0168-0139 | e6136adb-6d9e-4823-a9c1-f56976734747 | 1 | 2017-09-11 |
| 0168-0139-30 | GM - Gram | 0168-0139 | 403de9e2-33eb-4221-93ff-bba8eaf3f25a | 1 | 2017-09-11 |
| 0168-0139-60 | GM - Gram | 0168-0139 | 338875c3-e3ff-4ea7-bce8-0d8d7cb3746d | 1 | 2017-09-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLUOCINONIDE | ACTIVE INGREDIENT | 2W4A77YPAN | FLUOCINONIDE CREAM [STAT RX USA LLC] | 1 | |
| FLUOCINONIDE | ACTIVE MOIETY | 2W4A77YPAN | FLUOCINONIDE CREAM [STAT RX USA LLC] | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | 37ac77aa-ab34-4220-85f0-c58cf2781ce7 | 1 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | 37ac77aa-ab34-4220-85f0-c58cf2781ce7 | 1 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | 37ac77aa-ab34-4220-85f0-c58cf2781ce7 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0168-0139-15 | 00168013915 | 15 g in 1 TUBE (0168-0139-15) | 15 g | 1994-10-17 | 2021-04-30 | No | No | Current |
| 0168-0139-30 | 00168013930 | 30 g in 1 TUBE (0168-0139-30) | 30 g | 1994-10-17 | 2021-04-30 | No | No | Current |
| 0168-0139-60 | 00168013960 | 60 g in 1 TUBE (0168-0139-60) | 60 g | 1994-10-17 | 2021-04-30 | No | No | Current |