| NDC Code | 35573-456-00 |
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| Package Description | 100 TABLET in 1 BOTTLE (35573-456-00) |
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| Product NDC | 35573-456 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Butalbital And Acetaminophen |
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| Non-Proprietary Name | Butalbital And Acetaminophen |
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| Dosage Form | TABLET |
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| Usage | ORAL |
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| Start Marketing Date | 20221201 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA214088 |
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| Manufacturer | Burel Pharmaceuticals, LLC |
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| Substance Name | ACETAMINOPHEN; BUTALBITAL |
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| Strength | 325; 50 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Barbiturate [EPC], Barbiturates [CS] |
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| DEA Schedule | CIII |
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