| Product NDC: | 0054-8534 |
| Proprietary Name: | Loperamide Hydrochloride |
| Non Proprietary Name: | Loperamide Hydrochloride |
| Active Ingredient(s): | 1 ug/5mL & nbsp; Loperamide Hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-8534 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA073079 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19920430 |
| Package NDC: | 0054-8534-16 |
| Package Description: | 5 mL in 1 CUP, UNIT-DOSE (0054-8534-16) |
| NDC Code | 0054-8534-16 |
| Proprietary Name | Loperamide Hydrochloride |
| Package Description | 5 mL in 1 CUP, UNIT-DOSE (0054-8534-16) |
| Product NDC | 0054-8534 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Loperamide Hydrochloride |
| Dosage Form Name | SOLUTION |
| Route Name | ORAL |
| Start Marketing Date | 19920430 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | LOPERAMIDE HYDROCHLORIDE |
| Strength Number | 1 |
| Strength Unit | ug/5mL |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |