| NDC Code | 50580-342-01 |
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| Package Description | 1 BLISTER PACK in 1 CARTON (50580-342-01) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 50580-342 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Sudafed 12 Hour |
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| Non-Proprietary Name | Pseudoephedrine Hydrochloride |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20170901 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA075153 |
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| Manufacturer | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
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| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 120 |
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| Strength Unit | mg/1 |
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| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
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