Fluocinolone Acetonide
- Product NDC
- 0168-0058
- 11-digit product format
- 001680058
- Labeler code
- 0168
- Product ID
- 0168-0058_7b967ebe-35b7-4480-bbc4-7d3c87ba5358
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluocinolone acetonide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA088170
- Marketing category
- ANDA
- Marketing start
- 1982-12-16
- Marketing end
- 0000-00-00
- Substance
- FLUOCINOLONE ACETONIDE
- Active strength
- 0 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0adb2af5-1ecf-4df5-912b-16ae89228294 | Product name | 6 | 20240829 |
| 65f6255d-41cc-425f-ba54-b1bea4947886 | Product name | 5 | 20210930 |
| 5ba208e4-886f-44da-e218-ab4f4cad2c49 | Product name | 5 | 20190612 |
| e5a2793f-318b-72fd-b734-c44ecc6f6748 | Product name | 2 | 20190213 |
| 9e453f34-aacb-44d5-a119-c0e3dc1fca2a | Product name | 1 | 20160622 |
| 7df2570a-c555-4d82-9189-9247c722b62c | Product name | 1 | 20150402 |
| 85490a6b-2306-6bf2-c51b-eb63537dc2da | Product name | 1 | 20140508 |
| a78a3633-fd06-b0af-63b3-c714de3b3bfa | Product name | 1 | 20140508 |
| b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0168-0058-15 | 2023-12-18 | C162847 | 48780-1 | 9d75b9d0-85c9-f424-e053-dadaa90a57ce | f0b227f4-df9c-476c-95ce-31d864758f33 |
| 0168-0058-60 | 2023-12-18 | C162847 | 48780-1 | 9d75b9d0-85c9-f424-e053-dadaa90a57ce | f0b227f4-df9c-476c-95ce-31d864758f33 |
| 0168-0058-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-85c9-f424-e053-dadaa90a57ce | f0b227f4-df9c-476c-95ce-31d864758f33 |
| 0168-0058-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-85c9-f424-e053-dadaa90a57ce | f0b227f4-df9c-476c-95ce-31d864758f33 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0058-15 | GM - Gram | 0168-0058 | b5073426-5541-4399-869c-86c0f6bc144a | 1 | 2012-07-24 |
| 0168-0058-60 | GM - Gram | 0168-0058 | 573465ef-d6ce-4576-a1dc-2641147a17e4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1191302 | fluocinolone acetonide 0.01 % Topical Cream | PSN | cdc77f53-e9f6-486e-896a-069bc7ec47fd | 1 |
| 1191302 | fluocinolone acetonide 0.1 MG/ML Topical Cream | SCD | cdc77f53-e9f6-486e-896a-069bc7ec47fd | 1 |
| 1191302 | fluocinolone acetonide 0.01 % Topical Cream | SY | cdc77f53-e9f6-486e-896a-069bc7ec47fd | 1 |