Product NDC: | 54838-571 |
Proprietary Name: | Cetirizine Hydrochloride |
Non Proprietary Name: | Cetirizine Hydrochloride |
Active Ingredient(s): | 5 mg/5mL & nbsp; Cetirizine Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | SYRUP |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54838-571 |
Labeler Name: | Silarx Pharmaceuitcals, Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078876 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120511 |
Package NDC: | 54838-571-40 |
Package Description: | 120 mL in 1 BOTTLE, PLASTIC (54838-571-40) |
NDC Code | 54838-571-40 |
Proprietary Name | Cetirizine Hydrochloride |
Package Description | 120 mL in 1 BOTTLE, PLASTIC (54838-571-40) |
Product NDC | 54838-571 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Cetirizine Hydrochloride |
Dosage Form Name | SYRUP |
Route Name | ORAL |
Start Marketing Date | 20120511 |
Marketing Category Name | ANDA |
Labeler Name | Silarx Pharmaceuitcals, Inc |
Substance Name | CETIRIZINE HYDROCHLORIDE |
Strength Number | 5 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC] |