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] |