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 |