| Product NDC: | 13668-030 | 
| Proprietary Name: | CETIRIZINE HYDROCHLORIDE | 
| Non Proprietary Name: | CETIRIZINE HYDROCHLORIDE | 
| Active Ingredient(s): | 10 mg/1 & nbsp; CETIRIZINE HYDROCHLORIDE | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | TABLET | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 13668-030 | 
| Labeler Name: | Torrent Pharmaceuticals Limited | 
| Product Type: | HUMAN OTC DRUG | 
| FDA Application Number: | ANDA079191 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20100415 | 
| Package NDC: | 13668-030-25 | 
| Package Description: | 250 TABLET in 1 BOTTLE (13668-030-25) | 
| NDC Code | 13668-030-25 | 
| Proprietary Name | CETIRIZINE HYDROCHLORIDE | 
| Package Description | 250 TABLET in 1 BOTTLE (13668-030-25) | 
| Product NDC | 13668-030 | 
| Product Type Name | HUMAN OTC DRUG | 
| Non Proprietary Name | CETIRIZINE HYDROCHLORIDE | 
| Dosage Form Name | TABLET | 
| Route Name | ORAL | 
| Start Marketing Date | 20100415 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Torrent Pharmaceuticals Limited | 
| Substance Name | CETIRIZINE HYDROCHLORIDE | 
| Strength Number | 10 | 
| Strength Unit | mg/1 | 
| Pharmaceutical Classes |