Fluocinonide
- Product NDC
- 53002-9201
- 11-digit product format
- 530029201
- Labeler code
- 53002
- Product ID
- 53002-9201_7ac15c8e-de05-42cf-aebb-c5fff07da9ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluocinonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- RPK Pharmaceuticals, 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
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-9201-1 | 2025-01-30 | C162847 | 48780-1 | f386c64a-1768-0266-e053-dadaa90a7c1a | FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only |
| 53002-9201-2 | 2025-01-30 | C162847 | 48780-1 | f386c64a-1768-0266-e053-dadaa90a7c1a | FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only |
| 53002-9201-1 | 2023-06-07 | C162847 | 48780-1 | f386c64a-1768-0266-e053-dadaa90a7c1a | FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only |
| 53002-9201-2 | 2023-06-07 | C162847 | 48780-1 | f386c64a-1768-0266-e053-dadaa90a7c1a | FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only |
| 53002-9201-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1768-0266-e053-dadaa90a7c1a | FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only |
| 53002-9201-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-1768-0266-e053-dadaa90a7c1a | FLUOCINONIDE CREAM USP, 0.05% (Emulsified Base) FLUOCINONIDE CREAM USP, 0.05% FLUOCINONIDE OINTMENT USP, 0.05% 0262 0263 0264 FOR TOPICAL/EXTERNAL USE ONLY NOT FOR OPHTHALMIC USE Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-9201-1 | Fluocinonide | 15 g in 1 TUBE | CREAM | 15 | | 3 |
| 53002-9201-2 | Fluocinonide | 30 g in 1 TUBE | CREAM | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-9201 | FLUOCINONIDE CREAM [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 2 package rows | 20230609_428747a1-8c0e-4da1-99a3-d6f939645584.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-9201-1 | 53002920101 | 15 g in 1 TUBE (53002-9201-1) | 15 g | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-9201-2 | 53002920102 | 30 g in 1 TUBE (53002-9201-2) | 30 g | 2019-01-01 | 0000-00-00 | No | No | Current |