| NDC Code | 60687-278-86 |
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| Package Description | 3 TRAY in 1 CASE (60687-278-86) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-278-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-278-40) |
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| Product NDC | 60687-278 |
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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 | SYRUP |
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| Usage | ORAL |
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| Start Marketing Date | 20220603 |
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| End Marketing Date | 20240331 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA088008 |
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| Manufacturer | American Health Packaging |
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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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