| NDC Code | 0121-2316-50 |
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| Package Description | 5 TRAY in 1 CASE (0121-2316-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE |
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| Product NDC | 0121-2316 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
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| Non-Proprietary Name | Hydrocodone Bitartrate And Acetaminophen |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20130729 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA040838 |
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| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
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| Substance Name | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
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| Strength | 325; 7.5 |
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| Strength Unit | mg/15mL; mg/15mL |
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| Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
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| DEA Schedule | CII |
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