NDC 68791-103 – Dermotic
Fluocinolone Acetonide .11 mg/mL · Oil · Auricular (otic)
Product NDC68791-103
Product details
- Brand name
- Dermotic
- Generic name
- Fluocinolone acetonide
- Labeler
- Royal Pharmaceuticals
- Dosage form
- Oil
- Route
- Auricular (otic)
- Marketing category
- NDA · NDA019452
- Marketed since
- November 9, 2005
- Listing expires
- December 31, 2026
- Pharmacologic class
- Corticosteroid
Active ingredients
- Fluocinolone Acetonide .11 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 68791-103-20 | 1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) / 20 mL in 1 BOTTLE, DROPPER | Nov 9, 2005 |
Recalls mentioning this NDC
- D-0637-2021 Jun 30, 2021 · Class II
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. - D-1178-2014 Apr 2, 2014 · Class III
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.