| NDC Code | 50383-079-11 |
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| Package Description | 4 TRAY in 1 CASE (50383-079-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-079-10) |
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| Product NDC | 50383-079 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Acetaminophen And Codeine Phosphate |
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| Non-Proprietary Name | Acetaminophen And Codeine Phosphate |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 19960426 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA040119 |
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| Manufacturer | Hi-Tech Pharmacal Co., Inc. |
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| Substance Name | ACETAMINOPHEN; CODEINE PHOSPHATE |
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| Strength | 120; 12 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |
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| DEA Schedule | CV |
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