| NDC Code | 0121-1036-40 |
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| Package Description | 4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05) |
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| Product NDC | 0121-1036 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
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| Non-Proprietary Name | Hydrocodone Bitartrate And Homatropine Methylbromide |
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| Dosage Form | SOLUTION |
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| Usage | ORAL |
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| Start Marketing Date | 20240805 |
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| Marketing Category Name | NDA AUTHORIZED GENERIC |
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| Application Number | NDA005213 |
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| Manufacturer | PAI Holdings, LLC dba PAI Pharma |
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| Substance Name | HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
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| Strength | 1.5; 5 |
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| Strength Unit | mg/5mL; mg/5mL |
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| Pharmacy Classes | Opioid Agonist [EPC], Opioid Agonists [MoA] |
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| DEA Schedule | CII |
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