Fluocinolone Acetonide
- Product NDC
- 0168-0060
- 11-digit product format
- 001680060
- Labeler code
- 0168
- Product ID
- 0168-0060_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
- ANDA088169
- 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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0168-0060-15 | 2023-12-18 | C162847 | 48780-1 | 9d75b9d0-85c9-f424-e053-dadaa90a57ce | f0b227f4-df9c-476c-95ce-31d864758f33 |
| 0168-0060-60 | 2023-12-18 | C162847 | 48780-1 | 9d75b9d0-85c9-f424-e053-dadaa90a57ce | f0b227f4-df9c-476c-95ce-31d864758f33 |
| 0168-0060-15 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-85c9-f424-e053-dadaa90a57ce | f0b227f4-df9c-476c-95ce-31d864758f33 |
| 0168-0060-60 | 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 |
|---|---|---|---|---|---|
| 0168-0060-15 | GM - Gram | 0168-0060 | 6ebee8fa-2401-448d-8aba-44047ba5b60e | 1 | 2012-07-24 |
| 0168-0060-60 | GM - Gram | 0168-0060 | 7093645c-0d9c-4035-bec1-2ddc0328b9b5 | 1 | 2012-07-24 |