| NDC Code | 71656-064-10 |
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| Package Description | 1 BOTTLE, DROPPER in 1 CARTON (71656-064-10) / 10 mL in 1 BOTTLE, DROPPER |
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| Product NDC | 71656-064 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Hydrocortisone And Acetic Acid |
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| Non-Proprietary Name | Hydrocortisone And Acetic Acid Otic |
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| Dosage Form | SOLUTION |
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| Usage | AURICULAR (OTIC) |
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| Start Marketing Date | 20240223 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA012770 |
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| Manufacturer | Saptalis Pharmaceuticals, LLC |
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| Substance Name | ACETIC ACID; HYDROCORTISONE |
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| Strength | 20.75; 10.375 |
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| Strength Unit | mg/mL; mg/mL |
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| Pharmacy Classes | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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