| Product NDC: | 68016-125 | 
| Proprietary Name: | Premier Value Infants Ibuprofen | 
| Non Proprietary Name: | concetrated ibuprofen | 
| Active Ingredient(s): | 50 mg/1.25mL & nbsp; concetrated ibuprofen | 
| Administration Route(s): | ORAL | 
| Dosage Form(s): | SUSPENSION | 
| Coding System: | National Drug Codes(NDC) | 
| Product NDC: | 68016-125 | 
| Labeler Name: | Premier Value | 
| Product Type: | HUMAN OTC DRUG | 
| FDA Application Number: | ANDA079058 | 
| Marketing Category: | ANDA | 
| Start Marketing Date: | 20091201 | 
| Package NDC: | 68016-125-24 | 
| Package Description: | 1 BOTTLE in 1 CARTON (68016-125-24) > 30 mL in 1 BOTTLE | 
| NDC Code | 68016-125-24 | 
| Proprietary Name | Premier Value Infants Ibuprofen | 
| Package Description | 1 BOTTLE in 1 CARTON (68016-125-24) > 30 mL in 1 BOTTLE | 
| Product NDC | 68016-125 | 
| Product Type Name | HUMAN OTC DRUG | 
| Non Proprietary Name | concetrated ibuprofen | 
| Dosage Form Name | SUSPENSION | 
| Route Name | ORAL | 
| Start Marketing Date | 20091201 | 
| Marketing Category Name | ANDA | 
| Labeler Name | Premier Value | 
| Substance Name | IBUPROFEN | 
| Strength Number | 50 | 
| Strength Unit | mg/1.25mL | 
| Pharmaceutical Classes |