| NDC Code | 50580-539-16 |
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| Package Description | 2 BLISTER PACK in 1 CARTON (50580-539-16) > 8 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 50580-539 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Sudafed |
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| Proprietary Name Suffix | 12 Hour Pressure And Pain |
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| Non-Proprietary Name | Naproxen Sodium And 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 | 20101101 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA076518 |
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| Manufacturer | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
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| Substance Name | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 220; 120 |
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| Strength Unit | mg/1; mg/1 |
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