NDC 51672-3007 – Hydrocortisone and Acetic Acid
Hydrocortisone 10.4 mg/mL; Acetic Acid 20.8 mg/mL · Solution · Auricular (otic)
Product NDC51672-3007
Product details
- Brand name
- Hydrocortisone and Acetic Acid
- Generic name
- Hydrocortisone and Acetic Acid
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Dosage form
- Solution
- Route
- Auricular (otic)
- Marketing category
- ANDA · ANDA088759
- Marketed since
- April 28, 2005
- Listing expires
- December 31, 2026
- Pharmacologic class
- Corticosteroid
Active ingredients
- Hydrocortisone 10.4 mg/mL
- Acetic Acid 20.8 mg/mL
Uses, dosage, side effects and warnings for Hydrocortisone and acetic acid →
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 51672-3007-1 | 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE | Apr 28, 2005 |
Recalls mentioning this NDC
- D-0633-2024 Aug 21, 2024 · Class III
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during… - D-0089-2024 Nov 15, 2023 · Class III
Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during…