Fluocinonide
- Product NDC
- 21695-979
- 11-digit product format
- 216950979
- Labeler code
- 21695
- Product ID
- 21695-979_b4b09d4a-dbe9-4f41-ac04-d4f71743722f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA073481
- Marketing category
- ANDA
- Marketing start
- 2011-01-20
- 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 |
|---|---|---|---|---|---|
| 21695-979-30 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4c32-48b1-e053-8cdaa90a720a | FLUOCINONIDE OINTMENT USP, 0.05% FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-979-30 | Fluocinonide | 30 g in 1 TUBE | OINTMENT | 30 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-979-30 | GM - Gram | 21695-979 | fa28745a-4862-47ad-a4d8-6f3e19f5e806 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FLUOCINONIDE | ACTIVE INGREDIENT | 2W4A77YPAN | FLUOCINONIDE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| FLUOCINONIDE | ACTIVE MOIETY | 2W4A77YPAN | FLUOCINONIDE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| CASTOR OIL | INACTIVE INGREDIENT | D5340Y2I9G | FLUOCINONIDE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | FLUOCINONIDE OINTMENT [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 103457 | fluocinonide 0.05 % Topical Ointment | PSN | b4b09d4a-dbe9-4f41-ac04-d4f71743722f | 1 |
| 103457 | fluocinonide 0.0005 MG/MG Topical Ointment | SCD | b4b09d4a-dbe9-4f41-ac04-d4f71743722f | 1 |
| 103457 | fluocinonide 0.05 % Topical Ointment | SY | b4b09d4a-dbe9-4f41-ac04-d4f71743722f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 21695-979-30 | 21695097930 | 30 g in 1 TUBE | 30 g | Historical |