Fluocinonide
- Product NDC
- 53002-9200
- 11-digit product format
- 530029200
- Labeler code
- 53002
- Product ID
- 53002-9200_631bf3ca-aa3b-44a3-92f8-8ab67b8c7e3e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- RPK Pharmaceuticals, Inc.
- 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 [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|---|---|---|---|---|
| 53002-9200-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d1-0d65-f424-e053-dadaa90a57ce | FLUOCINONIDE CREAM, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only |
| 53002-9200-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d1-0d65-f424-e053-dadaa90a57ce | FLUOCINONIDE CREAM, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only |
| 53002-9200-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-0d65-f424-e053-dadaa90a57ce | FLUOCINONIDE CREAM, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only |
| 53002-9200-1 | 2020-12-17 | C162847 | 48780-1 | 9d75b9d1-0d65-f424-e053-dadaa90a57ce | FLUOCINONIDE CREAM, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only |
| 53002-9200-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0d65-f424-e053-dadaa90a57ce | FLUOCINONIDE CREAM, USP 0.05% FOR EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-9200-1 | Fluocinonide | 15 g in 1 TUBE | CREAM | 15 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-9200 | FLUOCINONIDE (FLUOCINONIDE) CREAM [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_a61ad82a-1889-4f8a-9627-bc81196cfbc2.zip |
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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-9200-1 | 53002920001 | 15 g in 1 TUBE (53002-9200-1) | 15 g | 2018-10-01 | 0000-00-00 | No | No | Current |