| NDC Code | 50580-670-20 |
| Package Description | 2 BLISTER PACK in 1 CARTON (50580-670-20) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 50580-670 |
| Product Type Name | HUMAN OTC DRUG |
| Proprietary Name | Sudafed 12 Hour |
| Non-Proprietary Name | Pseudoephedrine Hydrochloride |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Usage | ORAL |
| Start Marketing Date | 20080601 |
| Marketing Category Name | ANDA |
| Application Number | ANDA073585 |
| Manufacturer | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength | 120 |
| Strength Unit | mg/1 |