| NDC Code | 0054-0650-25 |
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| Package Description | 100 CAPSULE in 1 BOTTLE (0054-0650-25) |
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| Product NDC | 0054-0650 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Butalbital, Acetaminophen, Caffeine And Codeine Phosphate |
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| Non-Proprietary Name | Butalbital, Acetaminophen, Caffeine And Codeine Phosphate |
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| Dosage Form | CAPSULE |
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| Usage | ORAL |
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| Start Marketing Date | 20220509 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA215138 |
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| Manufacturer | Hikma Pharmaceuticals USA Inc. |
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| Substance Name | ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
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| Strength | 300; 50; 40; 30 |
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| Strength Unit | mg/1; mg/1; mg/1; mg/1 |
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| Pharmacy Classes | Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS] |
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| DEA Schedule | CIII |
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