| NDC Code | 68308-554-10 |
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| Package Description | 100 CAPSULE in 1 BOTTLE, PLASTIC (68308-554-10) |
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| Product NDC | 68308-554 |
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| Product Type Name | HUMAN PRESCRIPTION DRUG |
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| Proprietary Name | Zebutal |
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| Non-Proprietary Name | Butalbital, Acetaminophen And Caffeine |
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| Dosage Form | CAPSULE |
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| Usage | ORAL |
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| Start Marketing Date | 20131226 |
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| End Marketing Date | 20231031 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA089007 |
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| Manufacturer | Mayne Pharma 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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