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Sudafed
Sudafed - 50580-539-16 - (Naproxen sodium and Pseudoephedrine Hydrochloride)
Drug Information of Sudafed
| Product NDC: | 50580-539 |
| Proprietary Name: | Sudafed |
| Non Proprietary Name: | Naproxen sodium and Pseudoephedrine Hydrochloride |
| Active Ingredient(s): | 220; 120 mg/1; mg/1 & nbsp; Naproxen sodium and Pseudoephedrine Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Sudafed
| Product NDC: | 50580-539 |
| Labeler Name: | McNeil Consumer Healthcare Div. McNeil-PPC, Inc |
| Product Type: | HUMAN OTC DRUG |
| FDA Application Number: | ANDA076518 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20101101 |
Package Information of Sudafed
| Package NDC: | 50580-539-16 |
| Package Description: | 2 BLISTER PACK in 1 CARTON (50580-539-16) > 8 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
NDC Information of Sudafed
| NDC Code | 50580-539-16 |
| Proprietary Name | Sudafed |
| Package Description | 2 BLISTER PACK in 1 CARTON (50580-539-16) > 8 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Product NDC | 50580-539 |
| Product Type Name | HUMAN OTC DRUG |
| Non Proprietary Name | Naproxen sodium and Pseudoephedrine Hydrochloride |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20101101 |
| Marketing Category Name | ANDA |
| Labeler Name | McNeil Consumer Healthcare Div. McNeil-PPC, Inc |
| Substance Name | NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Strength Number | 220; 120 |
| Strength Unit | mg/1; mg/1 |
| Pharmaceutical Classes |
