Fluocinonide
- Product NDC
- 66116-512
- 11-digit product format
- 661160512
- Labeler code
- 66116
- Product ID
- 66116-512_4b4d9e67-2cca-4c64-80f2-b4f03950b6b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- MedVantx, Inc.
- Application
- ANDA072488
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Marketing end
- 0000-00-00
- Substance
- FLUOCINONIDE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66116-512-15 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e67b-cd31-e053-dbdaa90ab51a | FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE GEL USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 0265 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66116-512-15 | Fluocinonide | 15 g in 1 TUBE | CREAM | 15 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLUOCINONIDE | ACTIVE INGREDIENT | 2W4A77YPAN | FLUOCINONIDE CREAM [MEDVANTX, INC.] | 1 | |
| FLUOCINONIDE | ACTIVE MOIETY | 2W4A77YPAN | FLUOCINONIDE CREAM [MEDVANTX, INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | FLUOCINONIDE CREAM [MEDVANTX, INC.] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | FLUOCINONIDE CREAM [MEDVANTX, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | FLUOCINONIDE CREAM [MEDVANTX, INC.] | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | FLUOCINONIDE CREAM [MEDVANTX, INC.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103456 | fluocinonide 0.05 % Topical Cream | PSN | 4b4d9e67-2cca-4c64-80f2-b4f03950b6b3 | 1 |
| 103456 | fluocinonide 0.5 MG/ML Topical Cream | SCD | 4b4d9e67-2cca-4c64-80f2-b4f03950b6b3 | 1 |
| 103456 | fluocinonide 0.05 % Topical Cream | SY | 4b4d9e67-2cca-4c64-80f2-b4f03950b6b3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 66116-512-15 | 66116051215 | 15 g in 1 TUBE | 15 g | Historical |