Product NDC: | 16590-422 |
Proprietary Name: | IBUPROFEN |
Non Proprietary Name: | IBUPROFEN |
Active Ingredient(s): | 100 mg/5mL & nbsp; IBUPROFEN |
Administration Route(s): | ORAL |
Dosage Form(s): | SUSPENSION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16590-422 |
Labeler Name: | STAT Rx USA LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA076925 |
Marketing Category: | ANDA |
Start Marketing Date: | 20041208 |
Package NDC: | 16590-422-04 |
Package Description: | 1 BOTTLE in 1 CARTON (16590-422-04) > 120 mL in 1 BOTTLE |
NDC Code | 16590-422-04 |
Proprietary Name | IBUPROFEN |
Package Description | 1 BOTTLE in 1 CARTON (16590-422-04) > 120 mL in 1 BOTTLE |
Product NDC | 16590-422 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | IBUPROFEN |
Dosage Form Name | SUSPENSION |
Route Name | ORAL |
Start Marketing Date | 20041208 |
Marketing Category Name | ANDA |
Labeler Name | STAT Rx USA LLC |
Substance Name | IBUPROFEN |
Strength Number | 100 |
Strength Unit | mg/5mL |
Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |