| NDC Code | 70518-4467-0 |
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| Package Description | 20 TABLET in 1 BOTTLE, PLASTIC (70518-4467-0) |
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| Product NDC | 70518-4467 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Butalbital, Acetaminophen And Caffeine |
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| Non-Proprietary Name | Butalbital, Acetaminophen, And Caffeine |
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| Dosage Form | TABLET |
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| Usage | ORAL |
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| Start Marketing Date | 20250905 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA040511 |
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| Manufacturer | REMEDYREPACK INC. |
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| Substance Name | ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
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| Strength | 325; 50; 40 |
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| Strength Unit | 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], Methylxanthine [EPC], Xanthines [CS] |
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| DEA Schedule | CIII |
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