| Product NDC: | 50580-670 |
| Proprietary Name: | Sudafed 12 Hour |
| Non Proprietary Name: | Pseudoephedrine hydrochloride |
| Active Ingredient(s): | 120 mg/1 & nbsp; Pseudoephedrine hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50580-670 |
| Labeler Name: | McNeil Consumer Healthcare Div. McNeil-PPC, Inc |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | ANDA073585 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080601 |
| Package NDC: | 50580-670-10 |
| Package Description: | 1 BLISTER PACK in 1 CARTON (50580-670-10) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| NDC Code | 50580-670-10 |
| Proprietary Name | Sudafed 12 Hour |
| Package Description | 1 BLISTER PACK in 1 CARTON (50580-670-10) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 50580-670 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Pseudoephedrine hydrochloride |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20080601 |
| Marketing Category Name | ANDA |
| Labeler Name | McNeil Consumer Healthcare Div. McNeil-PPC, Inc |
| Substance Name | PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength Number | 120 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes |